Quality assessment of non-mydriatic fundus photographs for glaucoma screening in primary healthcare centres: a real-world study.

BACKGROUND: This study assessed the quality distribution of non-mydriatic fundus photographs (NMFPs) in real-world glaucoma screening and analysed its influencing factors. METHODS: This cross-sectional study was conducted in primary healthcare centres in the Yinzhou District, China, from 17 March to 3 December 2021. The quality distribution of bilateral NMFPs was assessed by the Digital Reading Department of the Eye Hospital of Wenzhou Medical University. Generalised estimating equations and logistic regression models identified factors affecting image quality. RESULTS: A total of 17 232 photographs of 8616 subjects were assessed. Of these, 11.9% of images were reliable for the right eyes, while only 4.6% were reliable for the left eyes; 93.6% of images were readable in the right eyes, while 90.3% were readable in the left eyes. In adjusted models, older age was associated with decreased odds of image readability (adjusted OR (aOR)=1.07, 95% CI 1.06~1.08, p<0.001). A larger absolute value of spherical equivalent significantly decreased the odds of image readability (all p<0.001). Media opacity and worse visual acuity had a significantly lower likelihood of achieving readable NMFPs (aOR=1.52, 95% CI 1.31~1.75; aOR=1.70, 95% CI 1.42~2.02, respectively, all p<0.001). Astigmatism axes within 31°~60° and 121°~150° had lower odds of image readability (aOR=1.35, 95% CI 1.11~1.63, p<0.01) than astigmatism axes within 180°±30°. CONCLUSIONS: The image readability of NMFPs in large-scale glaucoma screening for individuals 50 years and older is comparable with relevant studies, but image reliability is unsatisfactory. Addressing the associated factors may be vital when implementing ophthalmological telemedicine in underserviced areas. TRIAL REGISTRATION NUMBER: ChiCTR2200059277.

Perioperative time and economic impact of an intracameral combination of mydriatics and anaesthetics in routine cataract surgery.

PURPOSE: The aim of this study was to compare the perioperative time and economic impact of a licensed intracameral anaesthetic/mydriatic combination (Mydrane) during routine cataract surgery. METHODS: A real-life, prospective, comparative study was performed in 3 clinical centres in France. Preoperative, surgical, and post-operative times were determined for two mydriasis strategies using conventional preoperative mydriatics/anaesthetics eye drops (control regimen) or Mydrane administered at time of surgery. Staff, surgery schedules and drugs utilisation were collected over 12 surgery half-days. The total cost of each strategy was estimated based on treatment cost and nursing costs. RESULTS: The analysis included 112 routine cataract surgeries (57 surgeries using Mydrane and 55 using the topical regimen) without protocol deviations or complicated surgery. Overall, the mean time between administration of the first mydriatic eye drops or Mydrane and the end of the surgery was 27.4 ± 21.1 min in the Mydrane group vs. 90.3 ± 30.4 min in the control group (P < 0.0001). The total time of the procedure (from admission to discharge) was not significantly different between groups (P = 0.1611). On average, the extra cost of drugs per patient in the Mydrane group (€5.81) was almost balanced by the reduced nursing time (€5.57) with some variations between centres, due to different organisation including staff resource and consumable. CONCLUSIONS: The Mydrane strategy produced perioperative nursing time saving and cost reduction provided that adaptation and reorganisation of routine cataract surgery are implemented.

Potential Cost Savings Associated with a Multiuse Preoperative and Preinjection Eyedrop Protocol.

PURPOSE: To calculate the cost savings associated with a multiuse preoperative and preinjection eyedrop protocol. DESIGN: Economic analysis. PARTICIPANTS: Adults undergoing ophthalmic surgical procedures requiring preoperative dilation and intravitreal injections. METHODS: Economic modeling with scenario analysis was used to derive the value for cost savings secondary to a protocol in which perioperative mydriatic eyedrop bottles are used across multiple patients versus the current protocol in which drop bottles are wasted after single-patient use. Similar analyses were performed for a multiuse povidone-iodine protocol for intravitreal injections. Sensitivity analyses were used to test baseline model assumptions with varying degrees of waste and patient volume. RESULTS: The multiuse mydriatic protocol allowed for a 97.1% reduction in the number of eyedrop bottles required for the single-use protocol (1037 bottles vs. 35 850 bottles). This led to an estimated 5-year cost savings of approximately $240 000 (nominal) per institution (performing an average of 1434 cases/year) in the base case. This savings varied minimally in sensitivity analyses accounting for practical limitations (loss, expiration, or contamination) of multiuse containers, with savings of 97.54% to 95.00% for excess supply ranges from 0% to 100% in the multiuse protocol. Likewise, the cost savings varied minimally in sensitivity analyses for eyedrop sizes, with savings of 99.23% to 96.69% for mydriatic eyedrop sizes of 15 µl per drop to 65 µl per drop, respectively, in the multiuse protocol. Over a 5-year period, for povidone-iodine drops before performing intravitreal injection, the multiuse protocol required 153 bottles compared with 41 954 bottles (99.6% reduction) for the current single-use protocol, resulting in a nominal cost savings of $41 801, which varied minimally in sensitivity analyses. CONCLUSIONS: Multiuse perioperative mydriatic eyedrops are a viable option for cost and environmental waste reduction for ophthalmologic procedures and surgeries requiring dilation. Likewise, multiuse povidone-iodine may allow for large relative cost reduction for in-office procedures. The total potential savings over 5 years was estimated at more than $280 000 before adjusting for inflation.

Comparison of the Near Eye Tool for Refractive Assessment (NETRA) and non-cycloplegic subjective refraction.

Objective: The NETRA (Near Eye Tool for Refractive Assessment) is a smartphone-based refractive tool that allows for self-evaluation of refractive error. This study investigates the validity of the NETRA with and without cycloplegia to non-cycloplegic subjective refractions (SR). Methods and analysis: Participants underwent NETRA measurements without cycloplegia, and again after the administration of cycloplegia (cyclopentolate hydrochloride 1%). Non-cycloplegic SR were also performed. Variation of refractive measurements in symmetric dioptric power space were investigated using stereo-pair comets, hypothesis tests for variances and means. Bland-Altman plots were applied to better understand validity of the NETRA against non-cycloplegic SR. Coefficients of repeatability and intraclass correlation coefficients were also determined. Results: The sample included 22 women (64.7%) and 12 men (35.3%); most were indigenous Africans (52.9%) with mean age and SD of 20.24±1.95 years. Variation of refractive measurements were mainly stigmatic (spherical), and variation of NETRA measurements decreased after cycloplegia. The pre-cycloplegia NETRA measurements (and their means) for the right and left eyes were more negative (myopic) in power than the post-cycloplegia NETRA measurements and means. On average, eyes were approximately 1.25 D more myopic with the NETRA without cycloplegia. With cycloplegia, NETRA results were in closer agreement with non-cycloplegic SR for the same eyes. Conclusion: NETRA validity to SR, even in the absence of cycloplegia, suggests the instrument may be useful in geographical regions where self-refractions might be potentially helpful in addressing limitations in eye and vision care.

Cost analysis of mydriasis strategies in cataract surgery care in the Netherlands.

PURPOSE: To investigate the economic impact of an intracameral mydriatics and anesthetic agent (ICMA), topical mydriatics, and a mydriatic ocular insert in cataract patients. SETTING: One public hospital in the Netherlands. DESIGN: Prospective cohort study. METHODS: Resource use data were collected from a healthcare and societal perspective on the day of surgery. Other outcome parameters included pupil size, surgeon satisfaction, postoperative pain, and Catquest-9SF scores. RESULTS: A total of 368 patients were included, the mean costs per patient were €506 in the ICMA group (n = 122), €474 in the ocular insert group (n = 115), and €451 in the topical group (n = 131). The acquisition cost of ICMA was highest and resulted in longer surgical time. After correction for an imbalance in the distribution of fast and slow surgeons, the mean costs in the ocular insert and topical groups were comparable (€450 vs €444). There was no statistically significant difference in the use of additional mydriatics intraoperatively (P = .521). The mean ratio of pupil size to white-to-white distance was lower in the ICMA group during all intraoperative measurements (P < .001) but similar between the topical and ocular insert groups (P range .11-.82). CONCLUSIONS: In the investigated setting in the Netherlands, ICMA was the most costly strategy. In addition, pupil size was lowest in the ICMA group but did not result in more additional mydriasis measures intraoperatively. The ocular insert was comparable with topical mydriatics in costs and pupil size. Implementation of ICMA could be considered when availability of nurses or physical space for perioperative care is limited.

Assessment of the duration of surgery and patient turnover after the incorporation of a standardized intracameral combination of mydriatics and anesthetics for cataract surgery.

PURPOSE: To evaluate changes in clinical outcomes, duration, and workflow of cataract surgery, before and after the introduction of a commercially available intracameral combination of 2 mydriatics (phenylephrine, tropicamide) and 1 anesthetic (lidocaine) (ICMA). SETTING: Service d'Ophtalmologie, Hôpital Bicêtre, Université Paris Sud., Le Kremlin-Bicêtre, France. DESIGN: Retrospective chart review. METHODS: Three series of patients who underwent cataract surgery were grouped according to when they had surgery: just before ICMA was approved (early 2016, Series I); just after implementation of ICMA as the standard procedure for surgery (late 2016, Series II); and 21 months after using ICMA routinely for surgery (2018, Series III). Data were collected on patient turnover during the day of surgery and surgical outcomes. RESULTS: The study population comprised of 51, 47, and 51 patients in Series I, II, and III respectively. There were no statistical differences between series in the mean change in corrected distance visual acuity from preoperatively to 1 month postoperatively and in complications (P > .05, all comparisons). The mean duration of surgery was significantly shorter in Series III and II, compared with Series I (13.18 ± 4.05 and 13.62 ± 5.26 vs 15.82 ± 6.01 minutes; P = .023 and P = .041, respectively). The mean patient rotation was statistically significantly shorter in Series III compared with Series I (41.50 ± 8.31 vs 47.79 ± 14.66 minutes, respectively; P = .028). CONCLUSIONS: Implementing ICMA as a routine procedure in cataract surgery resulted in similar vision and safety outcomes than the usual topical eyedrop regimen, while significantly reducing the total surgery and rotation times. Hence, patient turnover during the surgical session was optimized while maintaining safety and efficacy of the procedure.

Eliminating Visual Acuity and Dilated Fundus Examinations Improves Cost Efficiency of Performing Optical Coherence Tomogrpahy-Guided Intravitreal Injections.

PURPOSE: The clinic efficiency and cost savings achieved by eliminating formal visual acuity (VA) and dilated fundus examinations (DFEs) were assessed for established patients receiving optical coherence tomography (OCT)-guided intravitreal injections. DESIGN: Comparative cost analysis. METHODS: Two different treatment models were evaluated. The first model included patients undergoing routine VA assessment, DFEs, OCT imaging, and intravitreal injections. The second model eliminated the routine VA assessment and DFE while using OCT imaging through an undilated pupil followed by the intravitreal injection. The 2 models incorporated both bevacizumab and aflibercept. The number of patients per clinic day, the cost per visit, and the daily revenues were compared between the 2 models. RESULTS: Optimized schedules with and without VA assessments and DFEs allowed for 48 and 96 patients to be injected per day, respectively. Excluding drug costs, the cost per encounter for the visits with and without a DFE were $39.33 and $22.63, respectively. Including the drug costs, the costs per encounter for the visits with and without a DFE were $85.55 and $68.85 for bevacizumab and $1787.58 and $17770.88 for aflibercept, respectively. Once the reimbursements for each visit type were included, the clinics that eliminated the VA and DFEs were more cost efficient. CONCLUSION: Eliminating both VA assessments and DFEs for patients undergoing OCT-guided retreatment with intravitreal injections resulted in decreased exposure times between patients and clinic staff, decreased cost per encounter, and increased patient volumes per clinic day, resulting in improved clinic efficiency and safety while seeing more patients in a clinic day.

Accuracy of Autorefraction in Children: A Report by the American Academy of Ophthalmology.

PURPOSE: The purpose of this assessment is to evaluate the accuracy of autorefraction compared with cycloplegic retinoscopy in children. METHODS: Literature searches were last conducted in October 2019 in the PubMed and the Cochrane Library databases for studies published in English. The combined searches yielded 118 citations, of which 53 were reviewed in full text. Of these, 31 articles were deemed appropriate for inclusion in this assessment and subsequently assigned a level of evidence rating by the panel methodologists. Four articles were rated level I, 11 were rated level II, and 16 were rated level III articles. The 16 level III articles were excluded from this review. RESULTS: Thirteen of the 15 studies comparing cycloplegic autorefraction with cycloplegic retinoscopy found a mean difference in spherical equivalent or sphere of less than 0.5 diopters (D); most were less than 0.25 D. Even lower mean differences were found when evaluating the cylindrical component of cycloplegic autorefraction versus cycloplegic retinoscopy. Despite low mean variability, there was significant individual measurement variability; the 95% limits of agreement were wide and included clinically relevant differences. Comparisons of noncycloplegic with cycloplegic autorefractions found that noncyloplegic refraction tends to over minus by 1 to 2 D. CONCLUSIONS: Cycloplegic autorefraction is appropriate to use in pediatric population-based studies. Cycloplegic retinoscopy can be valuable in individual clinical cases to confirm the accuracy of cycloplegic autorefraction, particularly when corrected visual acuity is worse than expected or the autorefraction results are not consistent with expected findings.

Pupil expansion device use and operative outcomes with topical dilation vs intracameral epinephrine in resident-performed cataract surgery.

PURPOSE: To compare the use of topical dilation drops vs topical drops with the addition of intracameral epinephrine in resident-performed cataract surgery and the effects on pupil expansion device (PED) use, surgical costs, and surgical times. SETTING: Iowa City Veterans Affairs Medical Center, Iowa City, Iowa, USA. DESIGN: Retrospective chart review. METHODS: Resident-performed primary cataract surgical cases using topical dilation drops only or drops with the addition of intracameral epinephrine were analyzed for PED use, surgical time, and costs in all patients and in patients with a history of tamsulosin use. RESULTS: In the topical group, PEDs were used in 31.1% of cases compared with 13.5% of cases in the intracameral group (P < .0001). History of tamsulosin use was noted in about one third of cases in both groups. For patients with a history of tamsulosin use, PED use decreased from 52.7% in the topical cases to 17.9% in the intracameral group (P < .0001). Surgical times were on average 7.1 minutes slower with PED use than without PED use. There was a medication savings of $50.44 USD per case in the intracameral group compared with the topical group. Factoring in the $100 to $130 USD per PED used, total surgical costs were $19 267 USD less in the intracameral group over 6 months. CONCLUSIONS: Intracameral epinephrine with lidocaine decreases the need for PED use during cataract surgery, lowers intraoperative costs, and improves efficiency compared with topical dilation drops alone.

Why Miss the Chance? Incidental Findings while Telescreening for Diabetic Retinopathy.

PURPOSE: To report on incidental pathological findings met while screening for Diabetic Retinopathy (DR) in Diabetes Clinics (DC) by ophthalmologist-graded digital fundus imaging. METHODS: At the DC of Pescara (central Italy), for 3,859 eyes of 1,930 consecutive patients having not undergone fundus examination in the last year, two mydriatic fundus digital images, taken with a CenterVue DRS Digital Retinal Camera, were sent along with Best Corrected Visual Acuity, on a "store-and-forward" basis, to an ophthalmologist trained in DR screening, and graded according to the UK Diabetic Eye Screening Programme. Incidental fundus abnormalities other than DR were reported. RESULTS: No adverse event to mydriasis was reported. One hundred and eighty eyes (4.66%) were ungradable. Among the 3,679 gradable ones, 1,105 (30.04%) showed different degrees of DR (R1 to R3), and 126 (3.42%) maculopathy (M1). Any Age-Related Macular Degeneration was present in 387 eyes (10.52%), any optic disc and parapapillary area features suspect for glaucoma in 562 eyes (15.27%), any hypertensive retinopathy in 1,263 eyes (34.33%), vitreoretinal interface disease in 252 eyes (6.84%), myopic choroidopathy in 92 eyes (2.50%), disc pallor in 31 eyes (0.84%). Mean time was 5 min for screening, 2 min for grading. CONCLUSION: Teleretinography is a well-established, cost-effective procedure in DR screening. Along with increased attendance, locating a digital camera in a DC with a retina-specialist grader results in finding fundus pathologies also beyond DR, very similarly to fundus examination in an outpatient ophthalmic setting.

Medication Burden for Patients With Bacterial Keratitis.

PURPOSE: To understand medication use and patient burden for treatment of bacterial keratitis (BK). METHODS: A retrospective study was conducted examining medical records of adult patients with BK in an academic cornea practice. Data collected included medications used in the treatment of BK, dosing of medications, and the number and total duration of clinical encounters. Costs of medications were estimated using the average wholesale pharmacy price. Linear regression analysis was used to investigate associations of medication use with patient demographics and corneal culture results and reported with beta estimates (ß) and 95% confidence intervals (95% CIs). RESULTS: Forty-eight patients with BK (56% female) were studied. Patients were treated for a median of 54 days with 10 visits, 5 unique medications, 587 drops, and 7 prescriptions. The estimated median medication cost was $933 (interquartile range: $457-$1422) US dollars. Positive bacterial growth was significantly associated with more visits (ß: 6.16, 95% CI: 1.75-10.6, P = 0.007), more days of treatment (ß: 86.8, 95% CI: 10.8-163, P = 0.026), more prescribed medications (ß: 2.86, 95% CI: 1.04-4.67, P = 0.003), and more doses of medications (ß: 796, 95% CI: 818-1412, P = 0.012) compared with patients who did not undergo corneal scraping. Patients were prescribed 132 more drops of medication for every 10 years of older age (ß: 132, 95% CI: 18.2-246, P = 0.024). Sex and income were not associated with medication burden or treatment length. CONCLUSIONS: Older patients and those with positive cultures incur the most medication burden in treatment of BK. Providers should be aware of medication usage and cost burden as it may affect compliance with treatment.

Characteristics Associated with Adherence to Annual Dilated Eye Examinations among US Patients with Diagnosed Diabetes.

PURPOSE: To identify the characteristics that are associated with adherence to annual diabetic eye exams and patient awareness of retinopathy using a nationally representative sample from the United States. DESIGN: Cross-sectional, secondary analysis. PARTICIPANTS: National Health and Nutrition Examination Survey (NHANES) participants from 2005 to 2016 aged 20 years and older with diabetes mellitus. METHODS: The NHANES collected surveys every 2 years from 2005 to 2016, which contained demographic information, clinical information, and time to last dilated eye exam. From 2005 to 2008, retinal photographs were taken of all participants older than 40 years of age. We used univariate and multivariable logistic regression to determine the demographic and clinical factors associated with adherence to annual diabetic eye examinations and those associated with correctly reporting their retinopathy status. MAIN OUTCOME MEASURE: Factors associated with adherence defined as having an eye exam within the preceding 12 or 24 months. RESULTS: From 2005 to 2016, NHANES surveyed 4072 individuals who represent 20 million Americans aged 20 years and older with self-report of diabetes. By using the adherence definitions of 12 and 24 months, 63.4% and 78.7%, respectively, were adherent to diabetic eye examinations. The nonadherence rates of 36.6% and 21.3% for this national estimate did not change from 2005 to 2016 (P = 0.7, logistic regression). Insurance status, age, education, income, cholesterol levels, duration of diabetes, and self-reported retinopathy were all significantly associated with adherence with both definitions (all P < 0.05, logistic regression). Insurance status had the highest predictive value, with 76% of Americans on combination private-public insurance adherent compared with 36% of uninsured. Most Americans with retinopathy incorrectly denied having the diagnosis (2 727 144/3 896 093 or 70%). CONCLUSIONS: Multiple variables were associated with nonadherence to eye exams, with insurance status having the strongest association. Adherence with annual eye exams has not improved over the past decade. The majority of patients with retinopathy are unaware of this diagnosis, including the majority of those with a dilated funduscopic examination in the past year. Further improvements in education and adherence may reduce the visual morbidity caused by diabetes.

Efficacy and safety of interventions to control myopia progression in children: an overview of systematic reviews and meta-analyses.

BACKGROUND: Myopia is a common visual disorder with increasing prevalence. Halting progression of myopia is critical, as high myopia can be complicated by a number of vision-compromising conditions. METHODS: Literature search was conducted in the following databases: Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica dataBASE (EMBASE), Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE) and Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) database. Systematic reviews and meta-analyses investigating the efficacy and safety of multiple myopia interventions vs control conditions, were considered. Methodological quality and quality of evidence of eligible studies were assessed using the ROBIS tool and GRADE rating. The degree of overlapping of index publications in the eligible reviews was calculated with the corrected covered area (CCA). RESULTS: Forty-four unique primary studies contained in 18 eligible reviews and involving 6400 children were included in the analysis. CCA was estimated as 6.2% and thus considered moderate. Results demonstrated the superior efficacy of atropine eyedrops; 1% atropine vs placebo (change in refraction: -0.78D, [- 1.30 to - 0.25] in 1 year), 0.025 to 0.05% atropine vs control (change in refraction: -0.51D, [- 0.60 to - 0.41] in 1 year), 0.01% atropine vs control (change in refraction: -0.50D, [- 0.76 to - 0.24] in 1 year). Atropine was followed by orthokeratology (axial elongation: - 0.19 mm, [- 0.21 to - 0.16] in 1 year) and novel multifocal soft contact lenses (change in refraction: -0.15D, [- 0.27 to - 0.03] in 1 year). As regards adverse events, 1% atropine induced blurred near vision (odds ratio [OR] 9.47, [1.17 to 76.78]) and hypersensitivity reactions (OR 8.91, [1.04 to 76.03]). CONCLUSIONS: Existing evidence has failed to convince doctors to uniformly embrace treatments for myopic progression control, possibly due to existence of some heterogeneity, reporting of side effects and lack of long-term follow-up. Research geared towards efficient interventions is still necessary.

Budget impact model of Mydrane®, a new intracameral injectable used for intra-operative mydriasis, from a UK hospital perspective.

BACKGROUND: During cataract surgery, maintaining an adequate degree of mydriasis throughout the entire operation is critical to allow for visualisation of the capsulorhexis and the crystalline lens. Good anaesthesia is also essential for safe intraocular surgery. Mydrane® is a new injectable intracameral solution containing two mydriatics (tropicamide 0.02% and phenylephrine 0.31%) and one anaesthetic (lidocaine 1%) that was developed as an alternative to the conventional topical pre-operative mydriatics used in cataract surgery. This study aimed to estimate the budget impact across a one year time frame using Mydrane® instead of topical dilating eye drops, for a UK hospital performing 3,000 cataract operations a year. METHODS: A budget impact model (BIM) was developed to compare the economic outcomes associated with the use of Mydrane® versus topical drops (tropicamide 0.5% and phenylephrine 10%) in patients undergoing cataract surgery in a UK hospital. The outcomes of interest included costs and resource use (e.g. clinician time, mydriasis failures, operating room time, number of patients per vial of therapy etc.) associated with management of mydriasis in patients undergoing cataract surgery. All model inputs considered the UK hospital perspective without social or geographical variables. Deterministic sensitivity analyses were also performed to assess the model uncertainty. RESULTS: Introduction of Mydrane® is associated with a cost saving of £6,251 over 3,000 cataract surgeries in one year. The acquisition costs of the Mydrane® (£18,000 by year vs. £3,330 for eye drops) were balanced by substantial reductions in mainly nurses' costs and time, plus a smaller contribution from savings in surgeons' costs (£20,511) and lower costs associated with auxiliary dilation (£410 due to avoidance of additional dilation methods). Results of the sensitivity analyses confirmed the robustness of the model to the variation of inputs. Except for the duration of one session of eye drop instillation and the cost of Mydrane®, Mydrane® achieved an incremental cost gain compared to tropicamide/phenylephrine eye drops. CONCLUSIONS: Despite a higher acquisition cost of Mydrane®, the budget impact of Mydrane® on hospital budgets is neutral. Mydrane® offers a promising alternative to traditional regimes using eye drops, allowing for a better patient flow and optimisation of the surgery schedule with neutral budget impact.

Assessment of Clinical Trials for Devices Intended to Control Myopia Progression in Children.

The increased prevalence of myopia in the United States and other regions of the world, and the sight-threatening problems associated with higher levels of myopia have led to great interest in research designed to reduce these rates. As most of the progression of myopia occurs in childhood, these investigations have been directed toward slowing the progression of myopia in children. Treatments described to potentially slow the progression of myopia have included pharmacological interventions, multifocal spectacles, and multifocal correction created by contact lenses. Although some contact lens clinical trials have demonstrated promising results in slowing the progression of myopia, many of these studies have significant limitations, including only short follow-up times, limited randomization, and incomplete masking. Such limitations have underscored the need to develop a more robust clinical study design, so that future studies can demonstrate whether contact lenses, as well as other medical devices, can be used in a safe and effective manner to control myopia progression. We review previous key studies and discuss study design and regulatory issues relevant to future clinical trials.

An evaluation of intracameral mydriasis for routine cataract surgery.

BACKGROUND: Intracameral Mydrane might facilitate a more streamlined cataract service and improve the patient experience. There is limited 'real-world' evidence of its use in a UK setting. METHODS: As part of a local evaluation of cataract surgery using intracameral Mydrane (group 2; n=60), data were collected on intraoperative pupil size and postoperative visual acuity (VA), as well as the rate of mechanical pupil dilation, intraoperative floppy iris syndrome (IFIS) and complications. Preoperative and theatre turnaround time was recorded and patients completed a validated measure of satisfaction postoperatively. Data were compared with a previous cohort subjected to the existing standard regime of preoperative topical mydriatics (group 1; n=60). RESULTS: Postoperative VA was comparable between groups (0.09±0.16 vs 0.08±0.15; p=0.59). Pupil size in group 2 was 7.0±1.0 mm prior to capsulorhexis and 6.5±0.29 mm after cortical aspiration, with a smaller pupil in patients on alpha-antagonists (4.7±1.1 mm; p=0.004) at this later time point. Comparing group 2 with group 1, preoperative waiting was less (87 vs 146 min; p<0.0001) and satisfaction was higher (76.0±11.2 vs 66.3±8.6; p<0.0001), although theatre turnaround time was longer (25 min vs 22 min). CONCLUSION: Intracameral mydriasis was clinically effective in most patients undergoing cataract surgery and might be associated with an improved patient experience and a more streamlined preoperative flow. Mydrane represents a licensed alternative to the off-label use of other intracameral mydriatic agents, but was not judged to be a cost-effective intervention for routine use in this particular setting.

Assessment of tilt and decentration of crystalline lens and intraocular lens relative to the corneal topographic axis using anterior segment optical coherence tomography.

PURPOSE: To investigate the tilt and decentration of the crystalline lens and the intraocular lens (IOL) relative to the corneal topographic axis using anterior segment ocular coherence tomography (AS-OCT). METHODS: A sample set of 100 eyes from 49 subjects (41 eyes with crystalline lenses and 59 eyes with IOLs) were imaged using second generation AS-OCT (CASIA2, TOMEY) in June and July 2016 at Okayama University. Both mydriatic and non-mydriatic images were obtained, and the tilt and decentration of the crystalline lens and the IOL were quantified. The effects of pupil dilation on measurements were also assessed. RESULTS: The crystalline lens showed an average tilt of 5.15° towards the inferotemporal direction relative to the corneal topographic axis under non-mydriatic conditions and 5.25° under mydriatic conditions. Additionally, an average decentration of 0.11 mm towards the temporal direction was observed under non-mydriatic conditions and 0.08 mm under mydriatic conditions. The average tilt for the IOL was 4.31° towards the inferotemporal direction relative to the corneal topographic axis under non-mydriatic conditions and 4.65° in the same direction under mydriatic conditions. The average decentration was 0.05 mm towards the temporal direction under non-mydriatic conditions and 0.08 mm in the same direction under mydriatic conditions. A strong correlation was found between the average tilt and decentration values of the crystalline lens and the IOL under both non-mydriatic and mydriatic conditions (all Spearman correlation coefficients, r ≥ 0.800; all P < 0.001). CONCLUSION: When measured using second generation AS-OCT, both the crystalline lens and the IOL showed an average tilt of 4-6° toward the inferotemporal direction relative to the corneal topographic axis and an average decentration of less than 0.12 mm towards the temporal direction. These results were not influenced by pupil dilation and they showed good repeatability.

Atropine for the Prevention of Myopia Progression in Children: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the published literature on the efficacy of topical atropine for the prevention of myopic progression in children. METHODS: Literature searches were last conducted in December 2016 in the PubMed database with no date restrictions, but were limited to studies published in English, and in the Cochrane Library database without any restrictions. The combined searches yielded 98 citations, 23 of which were reviewed in full text. Of these, 17 articles were deemed appropriate for inclusion in this assessment and subsequently were assigned a level of evidence rating by the panel methodologist. RESULTS: Seventeen level I, II, and III studies were identified. Most of the studies reported less myopic progression in children treated with atropine compared with various control groups. All 8 of the level I and II studies that evaluated primarily myopic progression revealed less myopic progression with atropine (myopic progression ranging from 0.04±0.63 to 0.47±0.91 diopters (D)/year) compared with control participants (myopic progression ranging from 0.38±0.39 to 1.19±2.48 D/year). In studies that evaluated myopic progression after cessation of treatment, a rebound effect was noted. Several studies evaluated the optimal dosage of atropine with regard to myopic progression, rebound after treatment cessation, and minimization of side effects. Lower dosages of atropine (0.5%, 0.1%, and 0.01%) were found to be slightly less effective during treatment periods of 1 to 2 years, but they were associated with less rebound myopic progression (for atropine 0.01%, mean myopic progression after treatment cessation of 0.28±0.33 D/year, compared with atropine 0.5%, 0.87±0.52 D/year), fewer side effects, and similar long-term results for myopic progression after the study period and rebound effect were considered. The most robust and well-designed studies were carried out in Asian populations. Studies involving patients of other ethnic backgrounds failed to provide sufficient evidence of an effect of atropine on myopic progression. CONCLUSIONS: Level I evidence supports the use of atropine to prevent myopic progression. Although there are reports of myopic rebound after treatment is discontinued, this seems to be minimized by using low doses (especially atropine 0.01%).

Early signal of diverted use of tropicamide eye drops in France.

AIMS: Tropicamide is a mydriatic drug used as eye-drops for diagnostic or therapeutic purposes. From 2013, a diverted use by intravenous route has been suspected in Eastern Europe in opioids users. To date, no signal of misuse has been identified in France. The aims of this study were to investigate any early signals of a diverted use of tropicamide eye drops and to collect information regarding motives for the misuse and tropicamide-induced effects. METHODS: Information was obtained at three levels: (1) at regional level (Midi-Pyrénées area), from reimbursement data and pharmacists' reports on suspicious requests; (2) at national level: from reimbursement data and prescriptions suggesting possible abuse from the OSIAP (Ordonnances Suspectes, Indicateur d'Abus Possible) survey; and (3) at international level: from VigiBase® reports and Web sources. Beta-blocker eye-drops were used as comparators. RESULTS: In France, in 2014-2015, 17 (0.91%, 95% CI [0.53-1.46%]) falsified prescriptions involving tropicamide were identified in the OSIAP survey (compared with 0%, 95% CI [0-0.19%] for beta-blockers). Moreover, 37 other suspicious prescriptions were presented in 2015 (notified in 2016). In Midi-Pyrénées, seven patients aged 35-49 were reimbursed for 19-45 vials of 10 ml, in a year. Since September 2014, the regional Addictovigilance Centre has received 91 notifications of suspicious requests to obtain tropicamide. In VigiBase® , two cases were identified but none in France. An increased interest in tropicamide-related Internet searches was observed from Russia and Ukraine. CONCLUSIONS: These results represent the first early warnings of a tropicamide diverted use in France. Tropicamide abusers would seek euphoria or hallucinations. The high doses involved in intravenous administration could lead to serious complications.