Myopic Shift over 5 Years after Pediatric Lensectomy with Primary Intraocular Lens Implantation.

PURPOSE: To report the change in refractive error over 5 years after primary intraocular lens (IOL) placement by age at surgery and to identify factors associated with the change in refractive error after 5 years. DESIGN: Prospective observational study at 61 pediatric eye care practices. PARTICIPANTS: One hundred eighty-six eyes of 152 children undergoing primary IOL implantation before 13 years of age for nontraumatic cataract. INTERVENTIONS: Cataract surgery with primary IOL placement. MAIN OUTCOME MEASURES: Five-year change in refractive error (spherical equivalent) by age at surgery and by immediate postoperative myopia versus emmetropia or hyperopia. RESULTS: Mean spherical equivalent myopic shift was -5.99 diopters (D; 95% confidence interval [CI], -7.64 to -4.34 D) when surgery was performed at 0 to younger than 1 year of age (n = 13), -3.53 D (-4.57 to -2.48 D) at 1 to younger than 2.5 years of age (n = 28), -1.91 D (-2.55 to -1.26 D) at 2.5 to younger than 4 years of age (n = 36), -2.04 D -2.60 to -1.49 D) at 4 to younger than 7 years of age (n = 60), and -0.83 D (-1.27 to -0.40 D) at 7 to younger than 13 years of age (n = 49; P < 0.01 for each comparison with the oldest group). Variability of myopic shift also decreased with increasing age (P < 0.01). In eyes of children 4 to younger than 13 years of age (small sample size precluded analysis of children younger than 4 years), significantly less mean change in refractive error was found over 5 years in eyes with myopia immediately after surgery (-0.69 D; 95% CI, -1.48 to 0.10 D; n = 27) than eyes with emmetropia or hyperopia immediately after surgery (-1.70 D; 95% CI, -2.10 to -1.31 D, n = 82; difference, -1.01 D [95% CI, -1.89 to -0.14 D]; P = 0.03). CONCLUSIONS: In this large, prospective cohort study of children younger than 13 years undergoing cataract surgery with primary IOL placement, greater and more variable myopic shift was found in children undergoing surgery at a younger age. Our finding of less myopic shift over 5 years in eyes with unintended immediate postoperative myopia deserves further study to guide IOL power selection more accurately. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Complications, Visual Acuity, and Refractive Error 3 Years after Secondary Intraocular Lens Implantation for Pediatric Aphakia.

PURPOSE: To report the cumulative incidence of complications and to describe refractive error and visual acuity (VA) outcomes in children undergoing secondary intraocular lens (IOL) implantation after previous surgery for nontraumatic cataract. DESIGN: Pediatric cataract registry. PARTICIPANTS: Eighty children (108 eyes: 60 bilateral, 48 unilateral) undergoing lensectomy at younger than 13 years of age. METHODS: Annual data collection from medical record review through 5 years after lensectomy. MAIN OUTCOME MEASURES: Cumulative incidence of newly emergent complications after secondary IOL implantation; refractive error and VA by 5 years after lensectomy. RESULTS: Median follow-up after secondary IOL implantation was 2.7 years (interquartile range [IQR], 0.8-3.3 years; range, 0.6-5.0 years) for bilateral and 2.1 years (range, 0.5-6.4 years) for unilateral cases. A common complication after secondary IOL implantation was a glaucoma-related adverse event (GRAE; glaucoma or glaucoma suspect); the cumulative incidence was 17% (95% confidence interval [CI], 3%-29%) in bilateral cases and 12% (95% CI, 0%-23%) in unilateral cases. The cumulative incidence of surgery for visual axis opacification was 2% (95% CI, 0%-7%) for bilateral cases and 4% (95% CI, 0%-10%) for unilateral cases. The median prediction error within 90 days of implantation was 0.88 diopter (D; IQR, -0.50 to +3.00 D) less hyperopic than intended among 21 eyes for bilateral cases and 1.50 D (IQR, -0.25 to +2.38 D) less among 19 unilateral cases. The median spherical equivalent refractive error at 5 years (at a median of 5.1 years of age) in eyes receiving a secondary IOL was +0.50 D (IQR, -2.38 to +2.94 D) for 48 bilateral cases and +0.06 D (IQR, -2.25 to +0.75 D) for 22 unilateral cases. Median monocular VA at 5 years was 20/63 (IQR, 20/50-20/100) for bilateral cases (n = 42) and 20/400 (IQR, 20/160-20/800) for unilateral cases (n = 33). CONCLUSIONS: Eyes with secondary IOL implantation have a risk of developing new GRAEs. Five years after lensectomy (approximately 2.5 years after secondary IOL implantation), the average refractive error was less hyperopic than desired given the anticipated further myopic shift before refraction stabilizes. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Relationships among Clinical Factors and Patient-reported Outcome Measures in Adults with Convergence Insufficiency.

SIGNIFICANCE: When exploring relationships among clinical measures and patient-reported outcome measures in adults with convergence insufficiency, worse symptoms (Convergence Insufficiency Symptom Survey [CISS] score) seemed to be correlated with worse reading function domain score (Adult Strabismus-20 quality-of-life questionnaire). After treatment, improved symptoms were associated with improved reading function quality of life. PURPOSE: This study aimed to explore relationships between clinical measures and patient-reported outcome measures in adults undergoing treatment for symptomatic convergence insufficiency. METHODS: In a prospective multicenter observational study, we evaluated adults with symptomatic convergence insufficiency (i.e., clinical measures of near exodeviation, receded near point of convergence, reduced near positive fusional vergence; CISS score ≥21). Fifty-seven participants treated with vision therapy/exercises (n = 35) or base-in prism (n = 22) were analyzed. Spearman correlation coefficients ( R ) were used to assess associations among the three clinical measures and patient-reported outcome measures (CISS, Diplopia Questionnaire, four Adult Strabismus-20 quality-of-life domains) before treatment (baseline) and after 10 weeks and 1 year. Associations were interpreted to be present when the lower limit of the 95% confidence interval (CI) was moderate to strong ( R ≥ 0.4). RESULTS: Among multiple exploratory analyses, the only moderate to strong baseline correlation was between worse CISS and worse Adult Strabismus-20 reading function scores ( R = 0.62; 95% CI, 0.43 to 0.76). Regarding change in measures with treatment, the only moderate to strong correlations were between improved CISS and improved Adult Strabismus-20 reading function scores for prism at 10 weeks ( R = 0.78; 95% CI, 0.52 to 0.91) and 1 year ( R = 0.85; 95% CI, 0.65 to 0.94) and for vision therapy/exercises at 1 year ( R = 0.78; 95% CI, 0.57 to 0.89). CONCLUSIONS: In exploratory analyses, we found positive correlations between CISS symptom scores and reading function quality-of-life scores. The absence of correlations between symptoms and individual clinical measures is consistent with clinical experience that, in convergence insufficiency, symptoms and clinical findings can be discordant.

Rasch-calibrated Intermittent Exotropia Symptom Questionnaire for Children.

SIGNIFICANCE: A rigorously designed and calibrated symptom questionnaire for childhood intermittent exotropia would be useful for clinical care and for research. PURPOSE: The aim of this study was to Rasch-calibrate and evaluate the previously developed Child Intermittent Exotropia Symptom Questionnaire using data gathered as part of a randomized clinical trial. METHODS: The questionnaire was administered to 386 children aged 3 to 10 years with intermittent exotropia who were enrolled in a randomized clinical trial comparing overminus with nonoverminus spectacles. Participants were followed at 6 and 12 months while on treatment and at 18 months off treatment. Factor analysis determined dimensionality, and Rasch analysis evaluated questionnaire performance. Logit values were converted to 0 (best) to 100 (worst). We evaluated differences in questionnaire scores between treatment groups and time points, and correlations with control scores. RESULTS: The Child Intermittent Exotropia Symptom Questionnaire was unidimensional. Rasch analysis indicated that there was no notable local dependence and no significant differential item functioning for sex or age. There was suboptimal targeting (mean logit, -1.62), and person separation was somewhat poor (0.95). There were no significant differences in the Child Intermittent Exotropia Symptom score between overminus spectacles and nonoverminus spectacles at 6, 12, and 18 months. Combining data from both treatment groups, there was significant improvement from baseline at all follow-up visits (e.g., mean change from baseline to 12 months, -6.6 points; 95% confidence interval, -8.6 to -4.6). Child Intermittent Exotropia Symptom scores were not correlated with distance or near control scores at 12 months. CONCLUSIONS: The seven-item Rasch-scored Child Intermittent Exotropia Symptom Questionnaire is limited by suboptimal performance. Future study is needed to determine whether it may be useful for clinical practice and for research.

Interventions for intermittent exotropia.

BACKGROUND: The clinical management of intermittent exotropia (X(T)) has been discussed extensively in the literature, yet there remains a lack of clarity regarding indications for intervention, the most effective form of treatment, and whether there is an optimal time in the evolution of the disease at which any given treatment should be carried out. OBJECTIVES: The objective of this review was to analyze the effects of various surgical and non-surgical treatments in randomized controlled trials (RCTs) of participants with intermittent exotropia, and to report intervention criteria and determine whether the treatment effect varies by age and subtype of X(T). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 1), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Science Information database (LILACS); the ISRCTN registry; ClinicalTrials.gov, and the WHO ICTRP. The date of the search was 20 January 2021. We performed manual searches of the British Orthoptic Journal up to 2002, and the proceedings of the European Strabismological Association (ESA), International Strabismological Association (ISA), and American Association for Pediatric Ophthalmology and Strabismus meeting (AAPOS) up to 2001. SELECTION CRITERIA: We included RCTs of any surgical or non-surgical treatment for intermittent exotropia. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. MAIN RESULTS: We included six RCTs, four of which took place in the United States, and the remaining two in Asia (Turkey, India). A total of 890 participants with basic or distance X(T) were included, most of whom were children aged 12 months to 10 years. Three of these six studies were from the 2013 version of this review. Overall, the included studies had a high risk of performance bias as masking of participants and personnel administering treatment was not possible. Two RCTs compared bilateral lateral rectus recession versus unilateral lateral rectus recession with medial rectus resection, but only one RCT (n = 197) reported on the primary outcomes of this review. Bilateral lateral rectus recession likely results in little difference in motor alignment at near (MD 1.00, 95% CI -2.69 to 4.69) and distance (MD 2.00, 95% CI -1.22 to 5.22) fixation as measured in pupillary distance using PACT (moderate-certainty evidence). Bilateral lateral rectus recession may result in little to no difference in stereoacuity at near fixation (risk ratio (RR) 0.77, 95% CI 0.35 to 1.71), adverse events (RR 7.36, 95% CI 0.39 to 140.65), or quality of life measures (low-certainty evidence). We conducted a meta-analysis of two RCTs comparing patching (n = 249) with active observation (n = 252), but were unable to conduct further meta-analyses due to the clinical and methodological heterogeneity in the remaining trials. We found evidence that patching was clinically more effective than active observation in improving motor alignment at near (mean difference (MD) -2.23, 95% confidence interval (CI) -4.02 to -0.44) and distance (MD -2.00, 95% CI -3.40 to -0.61) fixation as measured by prism and alternate cover test (PACT) at six months (high-certainty evidence). The evidence suggests that patching results in little to no difference in stereoacuity at near fixation (MD 0.00, 95% CI -0.07 to 0.07) (low-certainty evidence). Stereoacuity at distance, motor fusion test, and quality of life measures were not reported. Adverse events were also not reported, but study authors explained that they were not anticipated due to the non-surgical nature of patching. One RCT (n = 38) compared prism adaptation test with eye muscle surgery versus eye muscle surgery alone. No review outcomes were reported. One RCT (n = 60) compared lateral rectus recession and medial rectus plication versus lateral rectus recession and medial rectus resection. Lateral rectus recession and medial rectus plication may not improve motor alignment at distance (MD 0.66, 95% CI -1.06 to 2.38) (low-certainty evidence). The evidence for the effect of lateral rectus recession and medial rectus plication on motor fusion test performance is very uncertain (RR 0.92, 95% CI 0.48 to 1.74) (very low-certainty evidence). AUTHORS' CONCLUSIONS: Patching confers a clinical benefit in children aged 12 months to 10 years of age with basic- or distance-type X(T) compared with active observation. There is insufficient evidence to determine whether interventions such as bilateral lateral rectus recession versus unilateral lateral rectus recession with medial rectus resection; lateral rectus recession and medial rectus plication versus lateral rectus recession and medial rectus resection; and prism adaptation test prior to eye muscle surgery versus eye muscle surgery alone may confer any benefit.

Occlusion for stimulus deprivation amblyopia.

BACKGROUND: Stimulus deprivation amblyopia (SDA) develops due to an obstruction to the passage of light secondary to a condition such as cataract. The obstruction prevents formation of a clear image on the retina. SDA can be resistant to treatment, leading to poor visual prognosis. SDA probably constitutes less than 3% of all amblyopia cases, although precise estimates of prevalence are unknown. In high-income countries, most people present under the age of one year; in low- to middle-income countries, people are likely to be older at the time of presentation. The mainstay of treatment is correction of the obstruction (e.g., removal of the cataract) and then occlusion of the better-seeing eye, but regimens vary, can be difficult to execute, and traditionally are believed to lead to disappointing results. OBJECTIVES: To evaluate the effectiveness of occlusion therapy for SDA in an attempt to establish realistic treatment outcomes and to examine evidence of any dose-response effect and assess the effect of the duration, severity, and causative factor on the size and direction of the treatment effect. SEARCH METHODS: We searched CENTRAL (2018, Issue 12), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Embase.com; and five other databases. We used no date or language restrictions in the electronic searches. We last searched the databases on 12 December 2018. SELECTION CRITERIA: We planned to include randomized controlled trials (RCTs) and controlled clinical trials of participants with unilateral SDA with visual acuity worse than 0.2 LogMAR or equivalent. We specified no restrictions for inclusion based upon age, gender, ethnicity, comorbidities, medication use, or the number of participants. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: We identified no trials that met the inclusion criteria specified in the protocol for this review. AUTHORS' CONCLUSIONS: We found no evidence from RCTs or quasi-randomized trials on the effectiveness of any treatment for SDA. RCTs are needed in order to evaluate the safety and effectiveness of occlusion, duration of treatment, level of vision that can be realistically achieved, effects of age at onset and magnitude of visual defect, optimum occlusion regimen, and factors associated with satisfactory and unsatisfactory outcomes with the use of various interventions for SDA.

Intraoperative Findings in Consecutive Exotropia with and without Adduction Deficit.

PURPOSE: Consecutive exotropia may be associated with limited adduction, which has been reported to be caused by 1 or more anatomic abnormalities of rectus muscles or their insertions. We studied the relative frequency of grades of adduction deficit and the relative frequency of abnormal anatomic findings. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients undergoing surgery for consecutive exotropia. METHODS: Preoperative duction deficits were graded on a -5 (severe limitation) to 0 (normal) scale. Operative reports were reviewed to classify intraoperative factors: (1) medial rectus muscle attachment type (normal, abnormal [slipped or stretched scar], attached to pulley, behind pulley, or mixed [a tenuous normal attachment, but with muscle fibers also attached to the pulley or behind the pulley]), (2) medial rectus muscle distal fiber location (millimeters from original insertion), and (3) lateral rectus muscle tightness (normal, mild restriction, moderate restriction). MAIN OUTCOME MEASURES: Relationship of grade of adduction deficit to each intraoperative factor. RESULTS: Of 143 eyes, 124 (87%) had an adduction deficit. Eyes with abnormal (n = 23), pulley (n = 9), behind pulley (n = 8), or mixed (n = 7) attachments had worse adduction deficits than normal attachments (n = 96; P < 0.02). There was a significant correlation between distal medial rectus muscle fiber location (0-19.5 mm recessed) and grade of adduction deficit (P < 0.0001). Eyes with mild or moderate lateral rectus muscle tightness on forced duction testing (n = 48/143 eyes) had worse adduction deficits than eyes without tightness (P < 0.001). Nevertheless, despite overall correlation, there was considerable individual variability. For example, for -1 and -2 adduction deficits, medial rectus muscle attachment could be at the pulley, behind the pulley, or include the pulley (19/87 eyes [22%]), and the lateral rectus muscle was tight in 36 of 87 eyes (41%). CONCLUSIONS: Adduction deficits are common in patients with consecutive exotropia. Overall, more severe preoperative adduction deficits are associated with medial rectus muscle insertion abnormalities and abnormal forced ductions, but frequently there are exceptions. Severe medial rectus muscle insertion abnormalities, including lost muscles, may be found despite mild preoperative adduction deficits.

Interventions for dissociated vertical deviation.

BACKGROUND: The term "strabismus" describes misalignment of the eyes. One or both eyes may deviate inward, outward, upward, or downward. Dissociated vertical deviation (DVD) is a well-recognized type of upward drifting of one or both eyes, which can occur in children or adults. DVD often develops in the context of infantile- or childhood-onset horizontal strabismus, either esotropia (inward-turning) or exotropia (outward-turning). For some individuals, DVD remains controlled and can only be detected during clinical testing. For others, DVD becomes spontaneously "manifest" and the eye drifts up of its own accord. Spontaneously manifest DVD can be difficult to control and often causes psychosocial concerns. Traditionally, DVD has been thought to be asymptomatic, although some individuals have double vision. More recently it has been suggested that individuals with DVD may also suffer from eyestrain. Treatment for DVD may be sought either due to psychosocial concerns or because of these symptoms. The standard treatment for DVD is a surgical procedure; non-surgical treatments are offered less commonly. Although there are many studies evaluating different management options for the correction of DVD, a lack of clarity remains regarding which treatments are most effective. OBJECTIVES: The objective of this review was to determine the effectiveness and safety of various surgical and non-surgical interventions in randomized controlled trials of participants with DVD. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 8), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2015), EMBASE (January 1980 to August 2015), PubMed (1948 to August 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 3 February 2014), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 August 2015. SELECTION CRITERIA: We included randomized controlled trials (RCTs) of surgical and non-surgical interventions for the correction of DVD. DATA COLLECTION AND ANALYSIS: We used standard procedures expected by Cochrane. Two review authors independently completed eligibility screening, data abstraction, 'Risk of bias' assessment, and grading of the evidence. MAIN RESULTS: We found four RCTs eligible for inclusion in this review (248 eyes of 151 participants between the ages of 6 months to 22 years). All trials were assessed as having unclear risk of bias overall due to insufficient reporting of study methods. One trial was conducted in Canada and compared anteriorization of the inferior oblique muscle with resection versus anteriorization of the inferior oblique muscle alone; one in the USA compared superior rectus recession with posterior fixation suture versus superior rectus recession alone; and two in the Czech Republic compared anteriorization of the inferior oblique muscle versus myectomy of the inferior oblique muscle.Only one trial reported data that allowed analysis of the primary outcome for this review, the proportion of participants with treatment success. The difference between inferior oblique anteriorization plus resection versus inferior oblique anteriorization alone was uncertain when measured at least four months postoperatively (risk ratio 1.13, 95% confidence interval 0.60 to 2.11, 30 participants, very low-quality evidence). Three trials measured the magnitude of hyperdeviation, but did not provide sufficient data for analysis. All four trials reported a relatively low rate of adverse events; hypotropia, limited elevation, and need for repeat surgery were reported as adverse events associated with some of the surgical interventions. No trials reported any other secondary outcome specified for our review. AUTHORS' CONCLUSIONS: The four trials included in this review assessed the effectiveness of five different surgical procedures for the treatment of DVD. Nevertheless, insufficient reporting of study methods and data led to methodological concerns that undermine the conclusions of all studies. There is a pressing need for carefully executed RCTs of treatment for DVD in order to improve the evidence for the optimal management of this condition.

Associations between health-related quality of life and the decision to perform surgery for childhood intermittent exotropia.

OBJECTIVE: To assess associations between health-related quality of life (HRQOL) and the decision to perform strabismus surgery for children with intermittent exotropia. DESIGN: Retrospective chart review. PARTICIPANTS: Children with intermittent exotropia. METHODS: Included subjects, identified in a clinical practice, had assessment of HRQOL using the intermittent exotropia questionnaire (IXTQ), comprising child, proxy, and parent components (parent domains: function, psychosocial, and surgery). The IXTQ scores were evaluated for association with surgery, along with standard clinical measures: prism and alternate cover test (PACT), stereoacuity, and control score (mean of the 3 most recent scores). Included data were from preoperative examination (surgical cohort) or from most recent follow-up examination (nonsurgical cohort). Univariate and multivariate logistic regression analyses were performed, and relative risk (RR) ratios were calculated. Spearman rank correlations were calculated to identify highly correlated items. MAIN OUTCOME MEASURES: Association of individual factors with the decision to perform surgery, calculated using RR ratios. RESULTS: One hundred six children with intermittent exotropia (median age, 6 years; range, 2-16 years) were eligible for inclusion. Nineteen (18%) of 106 underwent surgery. Using all available data, the IXTQ proxy score, IXTQ parent function score, IXTQ parent psychosocial score, distance control score, near control score, near PACT, and Randot Preschool stereoacuity (Stereoptical Co, Inc, Chicago, IL) were associated with undergoing surgery (P<0.1). Sixty-nine of 106 patients had complete data on all factors identified in univariate analysis and were included in multivariate analyses. Fourteen (20%) of these 69 patients underwent surgery. In multivariate analyses, poor distance control score (RR, 1.83; 95% confidence interval [CI], 1.25-2.68) and reduced IXTQ parent function score (RR, 0.96; 95% CI, 0.92-0.99) were associated with surgical intervention. Repeat multivariate analyses retaining only 1 of the highly correlated items showed IXTQ proxy, IXTQ parent psychosocial, larger near PACT, and worse near control were also associated with surgery. CONCLUSIONS: After accounting for poorer exodeviation control at distance, reduced parent and proxy HRQOL were associated with undergoing strabismus surgery for childhood intermittent exotropia. Recognizing reduced parental HRQOL may be important, with a possible role for educational or counselling interventions.

Occlusion for stimulus deprivation amblyopia.

BACKGROUND: Stimulus deprivation amblyopia (SDA) develops due to an obstruction to the passage of light secondary to a condition such as cataract. The obstruction prevents formation of a clear image on the retina. SDA can be resistant to treatment, leading to poor visual prognosis. SDA probably constitutes less than 3% of all amblyopia cases, although precise estimates of prevalence are unknown. In developed countries, most patients present under the age of one year; in less developed parts of the world patients are likely to be older at the time of presentation. The mainstay of treatment is removal of the cataract and then occlusion of the better-seeing eye, but regimens vary, can be difficult to execute, and traditionally are believed to lead to disappointing results. OBJECTIVES: Our objective was to evaluate the effectiveness of occlusion therapy for SDA in an attempt to establish realistic treatment outcomes. Where data were available, we also planned to examine evidence of any dose response effect and to assess the effect of the duration, severity, and causative factor on the size and direction of the treatment effect. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2013), EMBASE (January 1980 to October 2013), the Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to October 2013), PubMed (January 1946 to October 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com ), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 October 2013. SELECTION CRITERIA: We planned to include randomized and quasi-randomized controlled trials of participants with unilateral SDA with visual acuity worse than 0.2 LogMAR or equivalent. We did not specify any restrictions for inclusion based upon age, gender, ethnicity, co-morbidities, medication use, or the number of participants. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study abstracts identified by the electronic searches. MAIN RESULTS: We did not identify any trials that met the inclusion criteria specified in the protocol for this review. AUTHORS' CONCLUSIONS: We found no evidence on the effectiveness of any treatment for SDA. Future randomized controlled trials are needed in order to evaluate the safety and effectiveness of occlusion, duration of treatment, level of vision that can be realistically achieved, effects of age at onset and magnitude of visual defect, optimum occlusion regimen, and factors associated with satisfactory and unsatisfactory outcomes with the use of various interventions for SDA.

Outcomes and Complications 5 Years After Surgery for Pediatric Cataract Associated With Persistent Fetal Vasculature.

PURPOSE: To report 5-year outcomes after surgery for cataract associated with persistent fetal vasculature (PFV). DESIGN: Clinical cohort study using pediatric cataract registry data collected annually from medical records. METHODS: This study included 64 children <13 years of age who were undergoing surgery for unilateral, nontraumatic cataract associated with PFV. Proportions with age-normal visual acuity (VA) and VA better than 20/200 at 5 years' follow-up were estimated. Cumulative incidences of complications and additional surgeries by 5 years were calculated. Outcomes were compared between eyes with unilateral PFV and eyes with unilateral non-PFV cataract from our registry. RESULTS: Forty-eight of 64 eyes were aphakic postoperatively (median age at surgery 2 months [range 1-13 months]) and 16 were pseudophakic (29 months [range 2-92 months]). Overall, 4 of 42 eyes (10% [95% confidence interval {CI} 3%-23%]) achieved age-normal VA. VA better than 20/200 was achieved in 17 (59% [95% CI 39%-76%]) unilateral aphakic PFV eyes and 44 (43% [95% CI 32%-54%]) unilateral non-PFV aphakic eyes (age-adjusted odds ratio = 1.90 [95% CI 0.81-4.50]; P = .14). The most common complication in aphakic PFV eyes was glaucoma-related adverse events (cumulative incidence 24% [95% CI 9%-37%]). There was no significant difference in glaucoma-related adverse events between PFV and non-PFV eyes in aphakic participants ≤1 year of age at lensectomy (age-adjusted hazard ratio = 1.20 [95% CI 0.54-2.64], P = .66). CONCLUSIONS: A wide range of visual outcomes for PFV cataract were observed with a 10% probability of achieving age-normal VA. There was an ongoing risk for the development of glaucoma-related adverse events in PFV eyes.

Quantifying diplopia with a questionnaire.

PURPOSE: To report a diplopia questionnaire (DQ) with a data-driven scoring algorithm. DESIGN: Cross-sectional study. PARTICIPANTS: To optimize questionnaire scoring, 147 adults with diplopic strabismus completed both the DQ and the Adult Strabismus-20 (AS-20) health-related quality-of-life (HRQOL) questionnaire. To assess test-retest reliability, 117 adults with diplopic strabismus. To assess responsiveness to surgery, 42 adults (46 surgeries). METHODS: The 10-item AS-20 function subscale score (scored 0-100) was defined as the gold standard for severity. A range of weights was assigned to the responses and the gaze positions (from equal weighting to greater weighting of primary and reading). Combining all response option weights with all gaze position weights yielded 382848 scoring algorithms. We then calculated 382848 Spearman rank correlation coefficients comparing each algorithm with the AS-20 function subscale score. MAIN OUTCOME MEASURES: To optimize scoring, Spearman rank correlation coefficients (measuring agreement) between DQ scores and AS-20 function subscale scores. For test-retest reliability, 95% limits of agreement and intraclass correlation coefficient (ICC). For responsiveness, change in DQ score. RESULTS: For the 382 848 possible scoring algorithms, correlations with AS-20 function subscale score ranged from -0.64 (best correlated) to -0.55. The best-correlated algorithm had response option weights of 5 for rarely, 50 for sometimes, and 75 for often, and gaze position weights of 40 for straight ahead in the distance, 40 for reading, 1 for up, 8 for down, 4 for right, 4 for left, and 3 for other, totaling 100. There was excellent test-retest reliability with an ICC of 0.89 (95% confidence interval, 0.84-0.92), and 95% limits of agreement were 30.9 points. The DQ score was responsive to surgery with a mean change of 51 ± 34 (P<0.001). CONCLUSIONS: We have developed a data-driven scoring algorithm for the DQ, rating diplopia symptoms from 0 to 100. On the basis of correlations with HRQOL, straight-ahead and reading positions should be highly weighted. The DQ has excellent test-retest reliability and responsiveness, and may be useful in both clinical and research settings.

Interventions for intermittent exotropia.

BACKGROUND: The clinical management of intermittent exotropia has been discussed extensively in the literature, yet there remains a lack of clarity regarding indications for intervention, the most effective form of treatment and whether or not there is an optimal time in the evolution of the disease at which any treatment should be carried out. OBJECTIVES: The objective of this review was to analyse the effects of various surgical and non-surgical treatments in randomised trials of participants with intermittent exotropia, and to report intervention criteria and determine the significance of factors such as age with respect to outcome. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library, Issue 4, 2012), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to May 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 May 2012. We are no longer searching the UK Clinical Trials Gateway (UKCTG) for this review. We manually searched the British Orthoptic Journal up to 2002, and the proceedings of the European Strabismological Association (ESA), International Strabismological Association (ISA) and American Academy of Paediatric Ophthalmology and Strabismus meeting (AAPOS) up to 2001. We contacted researchers who are active in the field for information about further published or unpublished studies. SELECTION CRITERIA: We included randomised controlled trials of any surgical or non-surgical treatment for intermittent exotropia. DATA COLLECTION AND ANALYSIS: Each review author independently assessed study abstracts identified from the electronic and manual searches. Author analysis was then compared and full papers for appropriate studies were obtained. MAIN RESULTS: We found one randomised trial that was eligible for inclusion. This trial showed that unilateral surgery was more effective than bilateral surgery for correcting the basic type of intermittent exotropia. AUTHORS' CONCLUSIONS: The available literature consists mainly of retrospective case reviews, which are difficult to reliably interpret and analyse. The one randomised trial included found unilateral surgery more effective than bilateral surgery for basic intermittent exotropia. However, across all identified studies, measures of severity and thus criteria for intervention are poorly validated, and there appear to be no reliable natural history data. There is therefore a pressing need for improved measures of severity, a better understanding of the natural history and carefully planned clinical trials of treatment to improve the evidence base for the management of this condition.

Association of preoperative sensory monofixation with surgical failure in adult-onset divergence insufficiency-type esotropia.

We investigated the frequency of sensory monofixation in patients with adult-onset divergence insufficiency esotropia and whether preoperative sensory monofixation was associated with surgical failure. Twenty-five patients with esotropia greater at distance than near who underwent bilateral medial rectus recessions were included. Near stereoacuity was measured preoperatively and 8 weeks postoperatively using the Randot Preschool test. Patients with best-corrected visual acuity worse than 0.3 logMAR in either eye or preoperative diplopia "rarely" or "never" in straight-ahead gaze at distance were excluded to minimize the inclusion of decompensated childhood strabismus. Sensory monofixation was defined as stereoacuity of 200 arcsec or worse and bifixation as 40 or 60 arcsec. Surgical failure was defined as esodeviation of >4Δ or exodeviation of >10Δ at distance or near, assessed 8 weeks (range, 6-17 weeks) postoperatively. We calculated the frequency of monofixation and surgical failure rates among patients with preoperative monofixation and those with preoperative bifixation. Preoperatively, sensory monofixation was common in divergence insufficiency-type esotropia (16 of 25 [64%]; 95% CI, 45%-83%). None of those with preoperative sensory monofixation had surgical failure, which does not support an association of surgical failure with preoperative monofixation.

Incidence of Glaucoma-Related Adverse Events in the First 5 Years After Pediatric Lensectomy.

Importance: Glaucoma can develop following cataract removal in children. Objective: To assess the cumulative incidence of glaucoma-related adverse events (defined as glaucoma or glaucoma suspect) and factors associated with risk of these adverse events in the first 5 years after lensectomy prior to 13 years of age. Design, Setting, and Participants: This cohort study used longitudinal registry data collected at enrollment and annually for 5 years from 45 institutional and 16 community sites. Participants were children aged 12 years or younger with at least 1 office visit after lensectomy from June 2012 to July 2015. Data were analyzed from February through December 2022. Exposures: Usual clinical care after lensectomy. Main Outcomes and Measures: The main outcomes were cumulative incidence of glaucoma-related adverse events and baseline factors associated with risk of these adverse events. Results: The study included 810 children (1049 eyes); 443 eyes of 321 children (55% female; mean [SD] age, 0.89 [1.97] years) were aphakic after lensectomy, and 606 eyes of 489 children (53% male; mean [SD] age, 5.65 [3.32] years) were pseudophakic. The 5-year cumulative incidence of glaucoma-related adverse events was 29% (95% CI, 25%-34%) in 443 eyes with aphakia and 7% (95% CI, 5%-9%) in 606 eyes with pseudophakia; 7% (95% CI, 5%-10%) of aphakic eyes and 3% (95% CI, 2%-5%) of pseudophakic eyes were diagnosed as glaucoma suspect. Among aphakic eyes, a higher risk for glaucoma-related adverse events was associated with 4 of 8 factors, including age less than 3 months (vs ≥3 months: adjusted hazard ratio [aHR], 2.88; 99% CI, 1.57-5.23), abnormal anterior segment (vs normal: aHR, 2.88; 99% CI, 1.56-5.30), intraoperative complications at time of lensectomy (vs none; aHR, 2.25; 99% CI, 1.04-4.87), and bilaterality (vs unilaterality: aHR, 1.88; 99% CI, 1.02-3.48). Neither of the 2 factors evaluated for pseudophakic eyes, laterality and anterior vitrectomy, were associated with risk of glaucoma-related adverse events. Conclusions and Relevance: In this cohort study, glaucoma-related adverse events were common after cataract surgery in children; age less than 3 months at surgery was associated with elevated risk of the adverse events in aphakic eyes. Children with pseudophakia, who were older at surgery, less frequently developed a glaucoma-related adverse event within 5 years of lensectomy. The findings suggest that ongoing monitoring for the development of glaucoma is needed after lensectomy at any age.

Improved control of intermittent exotropia with part-time patching.

We evaluated the effect of part-time patching versus observation on distance exodeviation control in post hoc analyses of 3- to <11-year-olds with intermittent exotropia who were assigned to either patching 3 hours/day or observation in a previously reported randomized clinical trial. The present analysis was limited to a subgroup of 306 participants who at distance fixation spontaneously manifested either a constant or intermittent exotropia or had prolonged recovery after monocular occlusion (a distance control score of 2 or worse using the 0-5 Office Control Score scale) at baseline. We assessed change in control at distance and near fixation, from baseline to 3 months and baseline to 6 months (1 month after discontinuing patching). We found greater improvement in the distance control score with patching than with observation at 3 months (mean difference, 0.4 points; 95% CI, 0.1-0.7) and 6 months (mean difference, 0.3 points; 95% CI, 0.02-0.6). These analyses suggest that part-time patching may improve distance control in children with intermittent exotropia and a control score ≥ 2; however, because this conclusion is based on post hoc subgroup analyses, further studies are needed.

Complications Occurring Through 5 Years Following Primary Intraocular Lens Implantation for Pediatric Cataract.

Importance: Lensectomy with primary intraocular lens (IOL) implantation is often used in the management of nontraumatic pediatric cataract, but long-term data evaluating the association of age and IOL location with the incidence of complications are limited. Objective: To describe the incidence of complications and additional eye surgeries through 5 years following pediatric lensectomy with primary IOL implantation and association with age at surgery and IOL location. Design, Setting, and Participants: This prospective cohort study used Pediatric Eye Disease Investigator Group cataract registry data from 61 institution- and community-based practices over 3 years (June 2012 to July 2015). Participants were children younger than 13 years without baseline glaucoma who had primary IOL implantation (345 bilateral and 264 unilateral) for nontraumatic cataract. Data analysis was performed between September 2021 and January 2023. Exposures: Lensectomy with primary IOL implantation. Main Outcome and Measures: Five-year cumulative incidence of complications by age at surgery (<2 years, 2 to <4 years, 4 to <7 years, and 7 to <13 years) and by IOL location (sulcus vs capsular bag) were estimated using Cox proportional hazards models. Results: The cohort included 609 eyes from 491 children (mean [SD] age, 5.6 [3.3] years; 261 [53%] male and 230 [47%] female). Following cataract extraction with primary IOL implantation, a frequent complication was surgery for visual axis opacification (VAO) (cumulative incidence, 32%; 95% CI, 27%-36%). Cumulative incidence was lower with anterior vitrectomy at the time of IOL placement (12%; 95% CI, 8%-16%) vs without (58%; 95% CI, 50%-65%), and the risk of undergoing surgery for VAO was associated with not performing anterior vitrectomy (hazard ratio [HR], 6.19; 95% CI, 3.70-10.34; P < .001). After adjusting for anterior vitrectomy at lens surgery, there were no differences in incidence of surgery for VAO by age at surgery (<2 years, HR, 1.35 [95% CI, 0.63-2.87], 2 to <4 years, HR, 0.86 [95% CI, 0.44-1.68], 4 to <7 years, HR, 1.06 [95% CI, 0.72-1.56]; P = .74) or by capsular bag vs sulcus IOL fixation (HR, 1.22; 95% CI, 0.36-4.17; P = .75). Cumulative incidence of glaucoma plus glaucoma suspect by 5 years was 7% (95% CI, 4%-9%), which did not differ by age after controlling for IOL location and laterality. Conclusions and Relevance: In this cohort study, a frequent complication following pediatric lensectomy with primary IOL was surgery for VAO, which was associated with primary anterior vitrectomy not being performed but was not associated with age at surgery or IOL location. The risk of glaucoma development across all ages at surgery suggests a need for long-term monitoring.

Comparing outcome criteria performance in adult strabismus surgery.

PURPOSE: To evaluate the performance of motor, diplopia, and health-related quality of life (HRQOL) criteria when analyzing outcomes of adult strabismus surgery. DESIGN: Cohort study. PARTICIPANTS: We studied 159 adults undergoing 171 strabismus surgeries. METHODS: All patients underwent clinical assessment preoperatively and 6 weeks postoperatively, including completion of Adult Strabismus-20 HRQOL questionnaires. Preoperatively, strabismus was classified as either diplopic (n = 117), nondiplopic (n = 38), or atypical diplopic (n = 16). To assess performance of motor, diplopia, and HRQOL criteria, success was defined a priori and applied separately and in combinations. For success: (1) motor criteria, <10 prism diopters by simultaneous prism cover test; (2) diplopia criteria, none or only rare in primary distance and for reading; (3) HRQOL criteria, exceeding previously reported 95% limits of agreement (LOA). MAIN OUTCOME MEASURES: Surgical success rate when applying motor, diplopia, and HRQOL criteria alone and in combinations. RESULTS: Overall, success rates were 90% for motor criteria, 74% for diplopia criteria, and 60% for HRQOL criteria. Combining criteria, the highest success rate was for motor plus diplopia criteria (67%) and the lowest success rate was when combining motor, diplopia, and HRQOL criteria (50%). CONCLUSIONS: Applying motor criteria alone yields the highest success rates when evaluating outcomes in adult strabismus surgery, but motor criteria do not fully represent the patient's postoperative status. Combining diplopia criteria with motor criteria provides a more clinically relevant standard for judging the success of adult strabismus surgery. For HRQOL criteria, exceeding 95% LOA at 6 weeks postoperatively seems to be a difficult hurdle to clear for some individual patients, and evaluating change in HRQOL score may be more useful in cohort studies.

Stereoacuity thresholds before and after visual acuity testing.

PURPOSE: To compare stereoacuity thresholds before and after visual acuity testing in patients with intermittent strabismus and in controls. DESIGN: Prospective cohort study. PARTICIPANTS AND CONTROLS: Eighty-eight patients (41 with intermittent strabismus and 47 controls) with measurable stereoacuity on their initial stereoacuity test were enrolled prospectively. METHODS: Stereoacuity was measured before and immediately after visual acuity testing using the near Preschool Randot and Distance Randot stereotests. Stereoacuity was transformed to log units for analysis. MAIN OUTCOME MEASURES: Change in stereoacuity thresholds (log seconds of arc [arcsec]). RESULTS: There was no overall deterioration in distance stereoacuity or near stereoacuity thresholds in either the intermittent strabismus or control groups. The mean change for patients with intermittent strabismus was 0.02 log arcsec (95% confidence interval [CI], -0.02 to 0.06) for near stereoacuity and 0.04 log arcsec (95% CI, -0.01 to 0.09) for distance stereoacuity. Control patients demonstrated a mean change of 0.03 log arcsec (95% CI, -0.01 to 0.06) for near stereoacuity and 0.01 log arcsec (95% CI, -0.06 to 0.08) for distance stereoacuity. These mean changes correspond to less than approximately one eighth of an octave. For individual patients, deterioration in stereoacuity beyond previously reported test-retest variability (0.6 log arcsec or more) was not observed in patients with intermittent strabismus or controls using either test. CONCLUSIONS: Stereoacuity thresholds do not deteriorate after visual acuity testing, and therefore measurements of stereoacuity do not need to precede visual acuity measurement or other tests that involve short periods of dissociation. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Interventions for unilateral and bilateral refractive amblyopia.

BACKGROUND: Refractive amblyopia is a common cause of reduced visual acuity in childhood, but optimal treatment is not well defined. This review examined the treatment effect from spectacles and conventional occlusion. OBJECTIVES: Evaluation of the evidence of the effectiveness of spectacles, occlusion or both in the treatment of unilateral and bilateral refractive amblyopia. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 1), MEDLINE (January 1950 to January 2012), EMBASE (January 1980 to January 2012), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to January 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 24 January 2012. We manually searched relevant conference proceedings. SELECTION CRITERIA: Randomised controlled trials of treatment for unilateral and bilateral refractive amblyopia by spectacles, with or without occlusion, were eligible. We included studies with participants of any age. DATA COLLECTION AND ANALYSIS: Two authors independently assessed abstracts identified by the searches. We obtained full-text copies and contacted study authors where necessary. Eleven trials were eligible for inclusion. We extracted data from eight. Insufficient data were present for the remaining three trials so data extraction was not possible. We identified no trials as containing participants with bilateral amblyopia. We performed no meta-analysis as there were insufficient trials for each outcome. MAIN RESULTS: For all studies mean acuity (standard deviation (SD)) in the amblyopic eye post-treatment was reported. All included trials reported treatment for unilateral refractive amblyopia.One study randomised participants to spectacles only compared to no treatment, spectacles plus occlusion compared to no treatment and spectacles plus occlusion versus spectacles only. For spectacles only versus no treatment, mean (SD) visual acuity was: spectacles group 0.31 (0.17); no treatment group 0.42 (0.19) and mean difference (MD) between groups was -0.11 (borderline statistical significance: 95% confidence interval (CI) -0.22 to 0.00). For spectacles plus occlusion versus no treatment, mean (SD) visual acuity was: full treatment 0.22 (0.13); no treatment 0.42 (0.19). Mean difference (MD) between the groups -0.20 (statistically significant: 95% CI -0.30 to -0.10). For spectacles plus occlusion versus spectacles only, MD was -0.09 (borderline statistical significance 95% CI -0.18 to 0.00). For two other trials that also looked at this comparison MD was -0.15 (not statistically significant 95% CI -0.32 to 0.02) for one trial and MD 0.01 (not statistically significant 95% CI -0.08 to 0.10) for the second trial.Three trials reviewed occlusion regimes.One trial looked at two hours versus six hours for moderate amblyopia: MD 0.01 (not statistically significant: 95% CI -0.06 to 0.08); a second trial 2003b reviewed six hours versus full-time for severe amblyopia: MD 0.03 (not statistically significant: 95% CI -0.08 to 0.14) and a third trial looked at six hours versus full-time occlusion: MD -0.12 (not statistically significant: 95% CI -0.27 to 0.03). One trial looked at occlusion supplemented with near or distance activities: MD-0.03 (not statistically significant 95% CI -0.09 to 0.03). One trial looked at partial occlusion and glasses versus glasses only: MD -0.01 (not statistically significant: 95% CI -0.05 to 0.03). AUTHORS' CONCLUSIONS: In some cases of unilateral refractive amblyopia it appears that there is a treatment benefit from refractive correction alone. Where amblyopia persists there is evidence that adding occlusion further improves vision. Despite advances in the understanding of the treatment of amblyopia it is currently still not possible to tailor individual treatment plans for amblyopia. The nature of any dose/response effect from occlusion still needs to be clarified. Partial occlusion appears to have the same treatment effect as glasses alone when started simultaneously for the treatment of unilateral refractive amblyopia. Treatment regimes for bilateral and unilateral refractive amblyopia need to be investigated further.