One-year follow-up of clinical convergence measures in children enrolled in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial.

PURPOSE: To assess the long-term stability of clinical measures of convergence (near point of convergence [NPC] and positive fusional vergence [PFV]) in participants enrolled in the Convergence Insufficiency Treatment Trial-Attention and Reading Trial (CITT-ART) who received 16 weeks of office-based vergence/accommodative therapy. METHODS: A total of 310 children, 9-14 years old, with symptomatic convergence insufficiency were enrolled in CITT-ART. Some 270 completed both their 16-week primary outcome visit followed by a 1-year follow-up visit. Of those 270, 181 (67%) were randomised to the vergence/accommodative therapy. Of the 181 in the vergence/accommodative group, 121 (67%) reported not receiving any additional treatment after the 16-week primary outcome visit. The mean change in NPC, PFV and percentages of children classified by the predetermined success criteria of convergence (normal NPC [<6 cm] and/or improved by ≥4 cm; normal PFV [passing Sheard's criterion and base-out break >15Δ] and/or improved by ≥10Δ) were compared at the 16-week primary outcome visit and 1 year later. RESULTS: Of the 121 who returned for their 1-year follow-up visit, there was no significant change in mean adjusted NPC (reduction of -0.2 cm; 95% CI: -1.0 to 0.5 cm) at 1 year. There was a statistically significant decrease in mean-adjusted PFV (-4.7∆; 95% CI: -6.5 to -2.8Δ) at 1 year. There were similar percentages of participants classified as 'normal' (p = 0.30), 'normal and/or improved' (p > 0.50) and 'normal and improved' (p > 0.14) based on NPC and PFV at the 1-year visit compared with the 16-week primary outcome visit. CONCLUSION: The improvements in NPC and PFV following 16 weeks of vergence/accommodative therapy (with no reported additional treatment thereafter) in children with symptomatic convergence insufficiency persisted 1-year post-treatment.

Preoperative binocular vision characteristics in the age-related cataract population.

BACKGROUND: This study is the first part of the "Binocular Vision Anomalies after Cataract Surgery" study that aimed to investigate the impact of cataract surgery on binocular vision status in adults with age-related cataract. This study aimed to investigate the preoperative binocular vision status of participants with age-related cataract. METHODS: Patients who elected to undergo bilateral cataract surgery (≥50 years of age) were recruited. Clinical measures of binocular vision including stereopsis, ocular alignment, fusional vergence, vergence facility, convergence amplitude and a symptom survey related to binocular vision anomalies were administered. A detailed classification protocol was established to identify the presence of binocular vision anomalies. The frequency of specific binocular vision anomalies and normative data of binocular vision measures were reported. RESULTS: A total of 73 subjects were evaluated. No strabismus was detected in the cohort. Non-strabismic binocular vision anomalies were detected in 24 subjects (32.9%), of whom 18 (24.7%) had convergence insufficiency, 3 (4.1%) had basic exophoria, 2 (2.7%) had convergence excess, and 1 (1.4%) had fusional vergence dysfunction. Decreased vergence facility and convergence amplitude were more common compared to the pre-presbyopes (P < 0.01). CONCLUSION: Binocular vision problems, especially convergence insufficiency, are common in the adults with age-related cataract. The study results demonstrate that the lack of normative binocular vision data for the presbyopic population is a significant gap in the literature and suggest the need for a study of normative data for this population. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (NCT03592615, USA).

Eye Tracking Metrics Differences among Uninjured Adolescents and Those with Acute or Persistent Post-Concussion Symptoms.

SIGNIFICANCE: Eye tracking assessments that include pupil metrics can supplement current clinical assessments of vision and autonomic dysfunction in concussed adolescents. PURPOSE: This study aimed to explore the utility of a 220-second eye tracking assessment in distinguishing eye position, saccadic movement, and pupillary dynamics among uninjured adolescents, those with acute post-concussion symptoms (≤28 days since concussion), or those with persistent post-concussion symptoms (>28 days since concussion). METHODS: Two hundred fifty-six eye tracking metrics across a prospective observational cohort of 180 uninjured adolescents recruited from a private suburban high school and 224 concussed adolescents, with acute or persistent symptoms, recruited from a tertiary care subspecialty concussion care program, 13 to 17 years old, from August 2017 to June 2021 were compared. Kruskal-Wallis tests were used, and Bonferroni corrections were applied to account for multiple comparisons and constructed receiver operating characteristic curves. Principal components analysis and regression models were applied to determine whether eye tracking metrics can augment clinical and demographic information in differentiating uninjured controls from concussed adolescents. RESULTS: Two metrics of eye position were worse in those with concussion than uninjured adolescents, and only one metric was significantly different between acute cases and persistent cases. Concussed adolescents had larger left and right mean, median, minimum, and maximum pupil size than uninjured controls. Concussed adolescents had greater differences in mean, median, and variance of left and right pupil size. Twelve metrics distinguished female concussed participants from uninjured; only four were associated with concussion status in males. A logistic regression model including clinical and demographics data and transformed eye tracking metrics performed better in predicting concussion status than clinical and demographics data alone. CONCLUSIONS: Objective eye tracking technology is capable of quickly identifying vision and pupillary disturbances after concussion, augmenting traditional clinical concussion assessments. These metrics may add to existing clinical practice for monitoring recovery in a heterogeneous adolescent concussion population.

Cataract surgery is not associated with post-operative binocular vision anomalies in age-related cataract patients.

PURPOSE: To compare the binocular vision status of patients pre- and post-cataract surgery, and to investigate the risk factors for patients who develop binocular vision anomalies post-surgery. METHODS: A prospective study of patients (≥50 years) who elected to undergo bilateral cataract surgery was implemented. A comprehensive binocular vision test battery including stereopsis, ocular alignment, fusional vergence, vergence facility, near point of convergence and the Convergence Insufficiency Symptom Survey (CISS) was administered before the first surgery and at the third visit after surgery on the second eye. A detailed diagnostic classification protocol was applied to identify the presence of binocular vision anomalies pre- and post-surgery. RESULTS: Seventy-three participants were included at baseline, 24 (33%) of whom were diagnosed with non-strabismic binocular vision anomalies (NSBVA), mainly convergence insufficiency (18/73, 25%). Fifty-one participants completed the post-operative evaluation, 17 (33%) of whom had NSBVA pre-surgery and 13 (26%) post-surgery (p = 0.48). There were a number of conversions from NSBVA to normal binocular vision and vice versa. Logistic regression showed that the adjusted odds ratio of pre-existing NSBVA diagnosis for predicting the risk of post-operative NSBVA was 6.37 (p < 0.01). There were no significant changes in most binocular vision measures post-surgery, except for a significant improvement in the CISS score (p < 0.01, Cohen's d = 0.83). CONCLUSIONS: Binocular vision anomalies, especially convergence insufficiency, are prevalent in the age-related cataract population. Cataract surgery does not appear to be a significant risk factor for the development of new binocular vision anomalies. A pre-existing binocular vision anomaly is the main risk factor for predicting a post-operative binocular vision anomaly in this population.

Does coexisting accommodative dysfunction impact clinical convergence measures, symptoms and treatment success for symptomatic convergence insufficiency in children?

PURPOSE: To determine whether coexisting accommodative dysfunction in children with symptomatic convergence insufficiency (CI) impacts presenting clinical convergence measures, symptoms and treatment success for CI. METHODS: Secondary data analyses of monocular accommodative amplitude (AA; push-up method), monocular accommodative facility (AF; ±2.00 D lens flippers) and symptoms (CI Symptom Survey [CISS]) in children with symptomatic CI from the Convergence Insufficiency Treatment Trial (N = 218) and CITT-Attention and Reading Trial (N = 302) were conducted. Decreased AA was defined as more than 2D below the minimum expected amplitude for age (15 - » age); those with AA < 5 D were excluded. Decreased AF was defined as <6 cycles per minute. Mean near point of convergence (NPC), near positive fusional vergence (PFV) and symptoms (CISS) were compared between those with and without accommodative dysfunction using analysis of variance and independent samples t-testing. Logistic regression was used to compare the effect of baseline accommodative function on treatment success [defined using a composite of improvements in: (1) clinical convergence measures and symptoms (NPC, PFV and CISS scores) or (2) solely convergence measures (NPC and PFV)]. RESULTS: Accommodative dysfunction was common in children with symptomatic CI (55% had decreased AA; 34% had decreased AF). NPC was significantly worse in those with decreased AA (mean difference = 6.1 cm; p < 0.001). Mean baseline CISS scores were slightly worse in children with coexisting accommodative dysfunction (decreased AA or AF) (30.2 points) than those with normal accommodation (26.9 points) (mean difference = 3.3 points; p < 0.001). Neither baseline accommodative function (p ≥ 0.12 for all) nor interaction of baseline accommodative function and treatment (p ≥ 0.50) were related to treatment success based on the two composite outcomes. CONCLUSIONS: A coexisting accommodative dysfunction in children with symptomatic CI is associated with worse NPC, but it does not impact the severity of symptoms in a clinically meaningful way. Concurrent accommodative dysfunction does not impact treatment response for CI.

Negative Fusional Vergence Is Abnormal in Children with Symptomatic Convergence Insufficiency.

SIGNIFICANCE: Deficits of disparity divergence found with objective eye movement recordings may not be apparent with standard clinical measures of negative fusional vergence (NFV) in children with symptomatic convergence insufficiency. PURPOSE: This study aimed to determine whether NFV is normal in untreated children with symptomatic convergence insufficiency and whether NFV improves after vergence/accommodative therapy. METHODS: This secondary analysis of NFV measures before and after office-based vergence/accommodative therapy reports changes in (1) objective eye movement recording responses to 4° disparity divergence step stimuli from 12 children with symptomatic convergence insufficiency compared with 10 children with normal binocular vision (NBV) and (2) clinical NFV measures in 580 children successfully treated in three Convergence Insufficiency Treatment Trial studies. RESULTS: At baseline, the Convergence Insufficiency Treatment Trial cohort's mean NFV break (14.6 ± 4.8Δ) and recovery (10.6 ± 4.2Δ) values were significantly greater (P < .001) than normative values. The post-therapy mean improvements for blur, break, and recovery of 5.2, 7.2, and 1.3Δ, respectively, were statistically significant (P < .0001). Mean pre-therapy responses to 4° disparity divergence step stimuli were worse in the convergence insufficiency group compared with the NBV group for peak velocity (P < .001), time to peak velocity (P = .01), and response amplitude (P < .001). After therapy, the convergence insufficiency group showed statistically significant improvements in mean peak velocity (11.63°/s; 95% confidence interval [CI], 6.6 to 16.62°/s), time to peak velocity (-0.12 seconds; 95% CI, -0.19 to -0.05 seconds), and response amplitude (1.47°; 95% CI, 0.83 to 2.11°), with measures no longer statistically different from the NBV cohort (P > .05). CONCLUSIONS: Despite clinical NFV measurements that seem greater than normal, children with symptomatic convergence insufficiency may have deficient NFV when measured with objective eye movement recordings. Both objective and clinical measures of NFV can be improved with vergence/accommodative therapy.

Effectiveness of vergence/accommodative therapy for accommodative dysfunction in children with convergence insufficiency.

PURPOSE: To determine the effectiveness of office-based vergence/accommodative therapy for improving accommodative amplitude and accommodative facility in children with symptomatic convergence insufficiency and accommodative dysfunction. METHODS: We report changes in accommodative function following therapy among participants in the Convergence Insufficiency Treatment Trial - Attention and Reading Trial with decreased accommodative amplitude (115 participants in vergence/accommodative therapy; 65 in placebo therapy) or decreased accommodative facility (71 participants in vergence/accommodative therapy; 37 in placebo therapy) at baseline. The primary analysis compared mean change in amplitude and facility between the vergence/accommodative and placebo therapy groups using analyses of variance models after 4, 8, 12 and 16 weeks of treatment. The proportions of participants with normal amplitude and facility at each time point were calculated. The average rate of change in amplitude and facility from baseline to week 4, and from weeks 4 to 16, were determined in the vergence/accommodative therapy group. RESULTS: From baseline to 16 weeks, the mean improvement in amplitude was 8.6 dioptres (D) and 5.2 D in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 3.5 D, 95% confidence interval (CI): 1.5 to 5.5 D; p = 0.01). The mean improvement in facility was 13.5 cycles per minute (cpm) and 7.6 cpm in the vergence/accommodative and placebo therapy groups, respectively (mean difference = 5.8 cpm, 95% CI: 3.8 to 7.9 cpm; p < 0.0001). Significantly greater proportions of participants treated with vergence/accommodative therapy achieved a normal amplitude (69% vs. 32%, difference = 37%, 95% CI: 22 to 51%; p < 0.0001) and facility (85% vs. 49%, difference = 36%, 95% CI: 18 to 55%; p < 0.0001) than those who received placebo therapy. In the vergence/accommodative therapy group, amplitude increased at an average rate of 1.5 D per week during the first 4 weeks (p < 0.0001), then slowed to 0.2 D per week (p = 0.002) from weeks 4 to 16. Similarly, facility increased at an average rate of 1.5 cpm per week during the first 4 weeks (p < 0.0001), then slowed to 0.6 cpm per week from weeks 4 to 16 (p < 0.0001). CONCLUSION: Office-based vergence/accommodative therapy is effective for improving accommodative function in children with symptomatic convergence insufficiency and coexisting accommodative dysfunction.

A Normative Study of Objective Measures of Disparity Vergence and Saccades in Children 9 to 17 Years Old.

SIGNIFICANCE: This study establishes normative data for objective outcome measures of vergence and saccade eye movements for the pediatric population. These data should facilitate future clinical trial design. PURPOSE: This study was designed to establish normative data for objective measures of disparity vergence and saccades in children between the ages 9 and 17 years using an objective binocular eye movement tracking system. METHODS: Participants (aged 9 to 17 years) had a vision examination including refraction, accommodative, and binocular vision testing. Eligibility criteria included 20/25 visual acuity with best correction, normal accommodation, and binocular vision. The ISCAN RK-826PCI binocular tracking system (ISCAN, Woburn, MA) was used to objectively record horizontal, symmetrical disparity vergence, and saccadic eye movements. Parameters assessed included peak velocity, time to peak velocity, latency, and response amplitude for both disparity vergence and saccades. RESULTS: One hundred eighteen participants were recruited (54.94% female; mean age, 13.5 years), and 77.1% (91/118) of the participants completed the assessment with usable data. A sample of the normative data included peak velocity (°/s), which had a mean ± standard deviation of 25.4 ± 2.9, 22.0 ± 3.0, 225 ± 16.7, and 332.5 ± 20.5 for 4° convergence, 4° divergence, 5° saccades, and 10° saccades, respectively. The mean ± standard deviation for the latency (seconds) measures were 0.28 ± 0.1, 0.28 ± 0.16, 0.23 ± 0.05, and 0.23 ± 0.05 for 4° convergence, 4° divergence, 5° saccades, and 10° saccades, respectively. CONCLUSIONS: Normative data enable researchers to have benchmark results for comparison with patient populations with binocular dysfunction. These objective disparity vergence measures can serve as outcome measures in future clinical trials to assess the effectiveness of therapeutic interventions by determining whether post-treatment results are similar to normal data.

2017 Glenn A. Fry Award Lecture: Establishing an Evidence-based Literature for Vision Therapy - A 25-year Journey.

In this article, I summarize the 2017 Glenn A. Fry Award Lecture and my journey from student, to clinician, to optometric educator, and finally researcher/vision scientist. Although content for many years of teaching and practicing vision therapy, the era of evidence-based health care created a level of discomfort, as it became evident that my area of interest, vision therapy, had minimal quality evidence to support its use. Joining forces with a group of exceptional colleagues, we established the Convergence Insufficiency Treatment Trial Investigator group, and we were able to achieve funding from the National Eye Institute for multiple randomized clinical trials. The results of our studies demonstrate that vision therapy is an effective treatment option for convergence insufficiency in children, and office-based therapy is more effective than home-based therapy. These studies also demonstrated that home-based pencil push-ups commonly used by both optometrists and ophthalmologists are no more effective than placebo therapy. More recently, working in a new arena of objective recording of vergence, accommodative, and versional eye movements, my research has demonstrated that objective outcome measures of vergence are feasible for future randomized clinical trials. In pilot studies with both naturally occurring convergence insufficiency and concussion-related convergence insufficiency, statistically significant and clinically meaningful changes have been found in both disparity vergence peak velocity and response amplitude after office-based vision therapy. With new evidence about the high prevalence of concussion-related convergence insufficiency, there is much work to be accomplished to study the effectiveness of vision therapy for convergence insufficiency as well as the underlying mechanisms for how and why vision therapy is effective.

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study.

PURPOSE: To evaluate changes in objective measures of disparity vergence after office-based vision therapy (OBVT) for concussion-related convergence insufficiency (CI) and determine the feasibility of using this objective assessment as an outcome measure in a clinical trial. METHODS: This was a prospective, observational trial. All participants were treated with weekly OBVT with home reinforcement. Participants included two adolescents and three young adults with concussion-related, symptomatic CI. The primary outcome measure was average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence included time to peak velocity, latency, accuracy, settling time, and main sequence. We also evaluated saccadic eye movements using the same outcome measures. Changes in clinical measures (near point of convergence, positive fusional vergence at near, Convergence Insufficiency Symptom Survey [CISS] score) were evaluated. RESULTS: There were statistically significant and clinically meaningful changes in all clinical measures for convergence. Four of the five subjects met clinical success criteria. For the objective measures, we found a statistically significant increase in peak velocity, response accuracy to 4° symmetrical convergence and divergence step stimuli, and the main sequence ratio for convergence step stimuli. Objective saccadic eye movements (5 and 10°) appeared normal pre-OBVT and did not show any significant change after treatment. CONCLUSIONS: This is the first report of the use of objective measures of disparity vergence as outcome measures for concussion-related convergence insufficiency. These measures provide additional information that is not accessible with clinical tests about underlying physiological mechanisms leading to changes in clinical findings and symptoms. The study results also demonstrate that patients with concussion can tolerate the visual demands (over 200 vergence and versional eye movements) during the 25-minute testing time and suggest that these measures could be used in a large-scale randomized clinical trial of concussion-related CI as outcome measures.

Stability of visual acuity improvement following discontinuation of amblyopia treatment in children aged 7 to 12 years.

OBJECTIVE: To assess the stability of visual acuity improvement during the first year after cessation of amblyopia treatment other than spectacle wear in children aged 7 to 12 years. METHODS: At the completion of a multicenter randomized trial during which amblyopia treated with patching and atropine improved by at least 2 lines on the electronic Early Treatment of Diabetic Retinopathy Study testing protocol, 80 patients aged 7 to 12 years were followed up while not receiving treatment (other than spectacle wear) for 1 year. MAIN OUTCOME MEASURE: Ten letters or more (> or =2 lines) worsening of visual acuity (measured using the electronic Early Treatment of Diabetic Retinopathy Study testing protocol) during the year following treatment discontinuation. RESULTS: During the year following cessation of treatment, the cumulative probability of worsening visual acuity (> or =2 lines) was 7% (95% confidence interval, 3%-17%); 82% of patients maintained an increase in visual acuity of 10 letters or more compared with their visual acuity before starting treatment. CONCLUSION: Visual acuity improvement occurring during amblyopia treatment is sustained in most children aged 7 to 12 years for at least 1 year after discontinuing treatment other than spectacle wear. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00094692.

Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children.

OBJECTIVE: To compare patching and atropine sulfate as treatments for moderate amblyopia in children 18 months after completion of a 6-month randomized trial. METHODS: In a randomized, multicenter (47 sites) clinical trial, 419 children younger than 7 years with amblyopia (20/40 to 20/100 in the affected eye) were assigned to receive either patching or atropine eye drops for 6 months. Between 6 months and 2 years, treatment was at the discretion of the investigator. Main Outcome Measure Visual acuity in the amblyopic eye and sound eye after 2 years. RESULTS: At 2 years, visual acuity in the amblyopic eye improved from baseline a mean of 3.7 lines in the patching group and 3.6 lines in the atropine group. The difference in visual acuity between treatment groups was small: 0.01 logMAR (95% confidence interval, -0.02 to 0.04). In both treatment groups, the mean amblyopic eye acuity was approximately 20/32, 1.8 lines worse than the mean sound eye acuity, which was approximately 20/20. CONCLUSIONS: Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia in children between 3 and 7 years of age at enrollment. However, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.

Randomized trial of treatment of amblyopia in children aged 7 to 17 years.

OBJECTIVE: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. METHODS: At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (> or =2 lines) by 24 weeks were considered responders. RESULTS: In the 7- to 12-year-olds (n = 404), 53% of the treatment group were responders compared with 25% of the optical correction group (P<.001). In the 13- to 17-year-olds (n = 103), the responder rates were 25% and 23%, respectively, overall (adjusted P = .22) but 47% and 20%, respectively, among patients not previously treated with patching and/or atropine for amblyopia (adjusted P = .03). Most patients, including responders, were left with a residual visual acuity deficit. CONCLUSIONS: Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years, although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia. For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching. We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment.

A randomized trial of atropine regimens for treatment of moderate amblyopia in children.

OBJECTIVE: To compare daily atropine to weekend atropine as prescribed treatments for moderate amblyopia in children younger than 7 years. DESIGN: Prospective, randomized multicenter clinical trial (30 sites). PARTICIPANTS: One hundred sixty-eight children younger than 7 years with amblyopia in the range of 20/40 to 20/80 associated with strabismus, anisometropia, or both. INTERVENTION: Randomization either to daily atropine or to weekend atropine for 4 months. Partial responders were continued on the randomized treatment until no further improvement was noted. MAIN OUTCOME MEASURE: Visual acuity (VA) in the amblyopic eye after 4 months. RESULTS: The improvement in VA of the amblyopic eye from baseline to 4 months averaged 2.3 lines in each group. The VA of the amblyopic eye at study completion was either (1) at least 20/25 or (2) better than or equal to that of the sound eye in 39 children (47%) in the daily group and 45 children (53%) in the weekend group. The VA of the sound eye at the end of follow-up was reduced by 2 lines in one patient in each group. Stereoacuity outcomes were similar in the 2 groups. CONCLUSIONS: Weekend atropine provides an improvement in VA of a magnitude similar to that of the improvement provided by daily atropine in treating moderate amblyopia in children 3 to 7 years old. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

A randomized trial of patching regimens for treatment of moderate amblyopia in children.

OBJECTIVE: To compare 2 hours vs 6 hours of daily patching as treatments for moderate amblyopia in children younger than 7 years. METHODS: In a randomized multicenter (35 sites) clinical trial, 189 children younger than 7 years with amblyopia in the range of 20/40 to 20/80 were assigned to receive either 2 hours or 6 hours of daily patching combined with at least 1 hour per day of near visual activities during patching.Main Outcome Measure Visual acuity in the amblyopic eye after 4 months. RESULTS: Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the visual acuity of the amblyopic eye from baseline to 4 months averaged 2.40 lines in each group (P =.98). The 4-month visual acuity was at least 20/32 and/or improved from baseline by 3 or more lines in 62% of patients in each group (P>.99). CONCLUSION: When combined with prescribing 1 hour of near visual activities, 2 hours of daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by 6 hours of daily patching in treating moderate amblyopia in children aged 3 to 7 years.

Risk of amblyopia recurrence after cessation of treatment.

BACKGROUND: Although amblyopia can be successfully treated with patching or atropine, there have been few prospective studies of amblyopia recurrence once treatment is discontinued. METHODS: We enrolled 156 children with successfully treated anisometropic or strabismic amblyopia (145 completed follow-up), who were younger than 8 years of age and who received continuous amblyopia treatment for the previous 3 months (prescribed at least 2 hours of daily patching or prescribed at least one drop of atropine per week) and who had improved at least 3 logMAR levels during the period of continuous treatment. Patients were followed off treatment for 52 weeks to assess recurrence of amblyopia, defined as a 2 or more logMAR level reduction of visual acuity from enrollment, confirmed by a second examination. Recurrence was also considered to have occurred if treatment was restarted because of a nonreplicated 2 or more logMAR level reduction of visual acuity. RESULTS: Recurrence occurred in 35 (24%) of 145 cases (95% confidence interval 17% to 32%) and was similar in patients who stopped patching (25%) and in patients who stopped atropine (21%). In patients treated with moderately intense patching (6 to 8 hours per day), recurrence was more common (11 of 26; 42%) when treatment was not reduced prior to cessation than when treatment was reduced to 2 hours per day prior to cessation (3 of 22; 14%, odds ratio 4.4, 95% confidence interval 1.0 to 18.7). CONCLUSIONS: Approximately one fourth of successfully treated amblyopic children experience a recurrence within the first year off treatment. For patients treated with 6 or more hours of daily patching, our data suggest that the risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced to 2 hours per day prior to cessation. A randomized clinical trial of no weaning versus weaning in successfully-treated amblyopia is warranted to confirm these observational findings.

Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials.

PURPOSE: To determine the effectiveness of weekend atropine for severe amblyopia from strabismus, anisometropia, or both combined among children 3 to 12 years of age. METHODS: We enrolled children into 2 prospective, randomized multicenter clinical trials of amblyopia therapy. Herein we report the results for severe amblyopia, 20/125 to 20/400. In Trial 1, 60 children 3 to 6 years of age (mean, 4.4 years) were randomized to weekend atropine plus a plano lens or weekend atropine plus full spectacle correction for the sound eye. In Trial 2, 40 children 7 to 12 years of age (mean, 9.3 years) were randomized to weekend atropine or 2 hours of daily patching. The visual acuity outcome was assessed at 18 weeks in Trial 1 and 17 weeks in Trial 2. RESULTS: In Trial 1, visual acuity improved by an average of 4.5 lines in the atropine plus correction group (95% CI, 3.2-5.8 lines) and 5.1 lines in the atropine plus plano lens group (95% CI, 3.7-6.4 lines). In Trial 2, visual acuity improved by an average of 1.5 lines in the atropine group (95% CI, 0.5-2.5 lines) and 1.8 lines in the patching group (95% CI, 1.1-2.6 lines). CONCLUSIONS: Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia. Improvement may be greater in younger children.

Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial.

OBJECTIVE: To compare patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 20/40-20/100) in children aged 7 to 12 years. METHODS: In a randomized, multicenter clinical trial, 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day. Main Outcome Measure Masked assessment of visual acuity in the amblyopic eye using the electronic Early Treatment Diabetic Retinopathy Study testing protocol at 17 weeks. RESULTS: At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group. The mean difference between groups (patching - atropine) adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority, -0.7, 3.1 letters). This difference met the prespecified definition for equivalence (confidence interval <5 letters). Visual acuity in the amblyopic eye was 20/25 or better in 15 participants in the atropine group (17%) and 20 in the patching group (24%; difference, 7%; 95% confidence interval, -3% to 17%). CONCLUSIONS: Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye. CLINICAL RELEVANCE: Atropine and patching achieve similar results among older children with unilateral amblyopia. TRIAL REGISTRATION: (clinicaltrials.gov) Identifier: NCT00315328.

A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children.

OBJECTIVE: To compare full-time patching (all hours or all but 1 hour per day) to 6 hours of patching per day, as prescribed treatments for severe amblyopia in children younger than 7 years. DESIGN: Prospective, randomized multicenter clinical trial (32 sites). PARTICIPANTS: One hundred seventy-five children younger than 7 years with amblyopia in the range of 20/100 to 20/400. INTERVENTION: Randomization either to full-time patching or to 6 hours of patching per day, each combined with at least 1 hour of near-visual activities during patching. MAIN OUTCOME MEASURE: Visual acuity in the amblyopic eye after 4 months. RESULTS: Visual acuity in the amblyopic eye improved a similar amount in both groups. The improvement in the amblyopic eye acuity from baseline to 4 months averaged 4.8 lines in the 6-hour group and 4.7 lines in the full-time group (P = 0.45). CONCLUSION: Six hours of prescribed daily patching produces an improvement in visual acuity that is of similar magnitude to the improvement produced by prescribed full-time patching in treating severe amblyopia in children 3 to less than 7 years of age.