Author: Ophthalmology

Incidence, Types, and Lifetime Risk of Adult-Onset Strabismus – Corrected Proof

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Objective: To describe the incidence and types of adult-onset strabismus in a geographically defined population.Design: Retrospectively reviewed population-based cohort.Participants: All adult (≥19 years of age) residents of Olmsted County, Minnesota, diagnosed with new-onset adult strabismus from January 1, 1985, through December 31, 2004.Methods: The medical records of all potential cases identified by the resources of the Rochester Epidemiology Project were reviewed.Main Outcome Measures: Incidence rates for adult-onset strabismus and its types.Results: Seven hundred fifty-three cases of new-onset adult strabismus were identified during the 20-year period, yielding an annual age- and gender-adjusted incidence rate of 54.1 cases (95% confidence interval, 50.2–58.0) per 100 000 individuals 19 years of age and older. The 4 most common types of new-onset strabismus were paralytic (44.2% of cases), convergence insufficiency (15.7%), small-angle hypertropia (13.3%), and divergence insufficiency (10.6%). The incidence of adult-onset strabismus overall and its 4 most common forms significantly increased with age (P < 0.001 for all), with a peak incidence in the eighth decade of life. The lifetime risk of being diagnosed with adult-onset strabismus was 4.0% in women and 3.9% in men.Conclusions: Paralytic strabismus was the most common subtype of new-onset adult strabismus in this population-based cohort. All of the most common forms of adult-onset strabismus increased with age, especially after the sixth decade of life. Further characterization of strabismus types found in this study is warranted to better define this disorder.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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RADIANCE: A Randomized Controlled Study of Ranibizumab in Patients with Choroidal Neovascularization Secondary to Pathologic Myopia – Corrected Proof

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Objective: To compare the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV).Design: Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study.Participants: Patients (N = 277) with visual impairment due to myopic CNV.Methods: Patients were randomized to receive ranibizumab on day 1, month 1, and thereafter as needed guided by VA stabilization criteria (group I, n = 106); ranibizumab on day 1 and thereafter as needed guided by disease activity criteria (group II, n = 116); or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators’ discretion from month 3 (group III, n = 55).Main Outcome Measures: Mean average best-corrected visual acuity (BCVA) change from baseline to month 1 through months 3 (primary) and 6, mean BCVA change and safety over 12 months.Results: Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 (group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both P < 0.0001). Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 (group II: +11.7 vs. group I: +11.9 ETDRS letters; P < 0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group I), +14.4 (group II), and +9.3 ETDRS letters (group III). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group I) and 2.0 (groups II and III) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred.Conclusions: Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month 3. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

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Author Reply – Corrected Proof

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Dr Fellman’s thoughtful comments allow for an opportunity to provide clarification with regard to the message conveyed in the editorial, “Things Go Better With Cataract Surgery.” First and foremost, I agree with Dr Fellman that blebless surgery is …

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Risk of Scar in the Comparison of Age-related Macular Degeneration Treatments Trials – Corrected Proof

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Objective: To describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration (AMD).Design: Prospective cohort study within a randomized clinical trial.Participants: Patients with no scar on color fundus photography (CFP) or fluorescein angiography (FA) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).Methods: Eyes were assigned to ranibizumab or bevacizumab treatment and to 1 of 3 dosing regimens for 2 years. Masked readers assessed CFP and FA. Baseline demographic characteristics, visual acuity, morphologic features on photography and optical coherence tomography (OCT), and genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios (aHRs) and associated 95% confidence intervals (CIs). Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish white tissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation.Main Outcome Measures: Scar formation.Results: Scar developed in 480 of 1059 eyes (45.3%) by 2 years. Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization (CNV) (aHR, 3.1; CI, 2.4–3.9) versus occult CNV, blocked fluorescence (aHR, 1.4; CI, 1.1–1.8), foveal retinal thickness >212 μm (aHR, 2.4; CI, 1.7–3.6) versus <120 μm, foveal subretinal tissue complex thickness >275 μm (aHR, 2.4; CI, 1.7–3.6) versus ≤75 μm, foveal subretinal fluid (aHR, 1.5; CI, 1.1–2.0) versus no subretinal fluid, and subretinal hyperreflective material (SHRM) (aHR, 1.7; CI, 1.3–2.3) versus no SHRM. Eyes with elevation of the retinal pigment epithelium had lower risk (aHR, 0.6; CI, 0.5–0.8) versus no elevation. Drug, dosing regimen, and genotype had no statistically significant association with scarring. Fibrotic scars developed in 24.7% of eyes, and nonfibrotic scars developed in 20.6% of eyes. Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity <20/40 were more likely to develop fibrotic scars.Conclusions: Approximately half of eyes enrolled in CATT developed scar by 2 years. Eyes with classic neovascularization, a thicker retina, and more fluid or material under the foveal center of the retina are more likely to develop scar.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

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Vitrectomy with Internal Limiting Membrane Peeling versus No Peeling for Idiopathic Full-Thickness Macular Hole – Corrected Proof

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Objective: To determine whether internal limiting membrane (ILM) peeling improves anatomic and functional outcomes of full-thickness macular hole (FTMH) surgery when compared with the no-peeling technique.Design: Systematic review and individual participant data (IPD) meta-analysis undertaken under the auspices of the Cochrane Eyes and Vision Group. Only randomized controlled trials (RCTs) were included.Participants and Controls: Patients with idiopathic stage 2, 3, and 4 FTMH undergoing vitrectomy with or without ILM peeling.Intervention: Macular hole surgery, including vitrectomy and gas endotamponade with or without ILM peeling.Main Outcome Measures: Primary outcome was best-corrected distance visual acuity (BCdVA) at 6 months postoperatively. Secondary outcomes were BCdVA at 3 and 12 months; best-corrected near visual acuity (BCnVA) at 3, 6, and 12 months; primary (after a single surgery) and final (after >1 surgery) macular hole closure; need for additional surgical interventions; intraoperative and postoperative complications; patient-reported outcomes (PROs) (EuroQol-5D and Vision Function Questionnaire-25 scores at 6 months); and cost-effectiveness.Results: Four RCTs were identified and included in the review. All RCTs were included in the meta-analysis; IPD were obtained from 3 of the 4 RCTs. No evidence of a difference in BCdVA at 6 months was detected (mean difference, −0.04; 95% confidence interval [CI], −0.12 to 0.03; P = 0.27); however, there was evidence of a difference in BCdVA at 3 months favoring ILM peeling (mean difference, −0.09; 95% CI, −0.17 to −0.02; P = 0.02). There was evidence of an effect favoring ILM peeling with regard to primary (odds ratio [OR], 9.27; 95% CI, 4.98–17.24; P < 0.00001) and final macular hole closure (OR, 3.99; 95% CI, 1.63–9.75; P = 0.02) and less requirement for additional surgery (OR, 0.11; 95% CI, 0.05–0.23; P < 0.00001), with no evidence of a difference between groups with regard to intraoperative or postoperative complications or PROs. The ILM peeling was found to be highly cost-effective.Conclusions: Available evidence supports ILM peeling as the treatment of choice for patients with idiopathic stage 2, 3, and 4 FTMH.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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The Spectrum of Ocular Alterations in Patients with β-Thalassemia Syndromes Suggests a Pathology Similar to Pseudoxanthoma Elasticum – Corrected Proof

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Purpose: To determine the prevalence and spectrum of ocular fundus abnormalities in patients with β-thalassemia and to investigate risk factors for their development.Design: Cross-sectional, observational study.Participants: A total of 255 patients with β-thalassemia major (TM) and β-thalassemia intermedia (TI) were consecutively recruited and investigated.Methods: Patients underwent best correct visual acuity, indirect ophthalmoscopy, and fundus photography, including fundus autofluorescence (FAF) and near-infrared reflectance imaging using a confocal scanning laser ophthalmoscope (cSLO). Hematologic parameters were determined, including mean ferritin levels, aspartate amino transferase, alanine amino transferase, calcium, pre-transfusion hemoglobin, history of splenectomy, and liver iron concentration. Factors associated with the ocular phenotype were assessed using logistic regression.Main Outcome Measures: Ocular phenotype as determined by clinical examination and used multimodal imaging.Results: A total of 153 patients (60.0%) affected by TM and 102 patients (40.0%) affected by TI participated, of whom 216 (84.7%) were receiving iron-chelating therapy. Ocular fundus abnormalities characteristic of pseudoxanthoma elasticum (PXE) were detected by cSLO in 70 of 255 patients (27.8%) and included peau d’orange (19.6%), angioid streaks (12.9%), pattern dystrophy-like changes (7.5%), and optic disc drusen (2.0%). Pseudoxanthoma elasticum–like changes were more frequent in patients with TI (P < 0.001). Patients with PXE-like fundus changes were older than patients without these fundus changes (P < 0.001). In both patients with TI and TM, age (P = 0.001) and splenectomy (P = 0.001) had the strongest association with presence of PXE-like fundus changes in multivariate analyses. A total of 43 of 255 patients (16.9%) showed increased retinal vascular tortuosity independently of the PXE-like fundus changes, which was associated with aspartate amino transferase (P = 0.036), hemoglobin (P = 0.008), and ferritin levels (P = 0.005).Conclusions: Pseudoxanthoma elasticum–like fundus changes are a frequent finding in patients with β-thalassemia. In TI, these changes increase with duration or severity of the disease. This particular ocular phenotype suggests an ocular pathology similar to PXE. Retinal vascular tortuosity may be an additional disease manifestation independent of the PXE-like syndrome. Patients with long-standing disease requiring iron-chelating treatment and a history of splenectomy need regular ophthalmic checkups because they are at risk of developing PXE-like fundus changes and potentially of subsequent choroidal neovascularization.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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Associations between Health-Related Quality of Life and the Decision to Perform Surgery for Childhood Intermittent Exotropia – Corrected Proof

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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.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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Defining the Limits of Normal Conjunctival Fornix Anatomy in a Healthy South Asian Population – Corrected Proof

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Purpose: Quantifying the extent of conjunctival fibrosis for documentation of progression in conjunctival scarring disease is a clinical challenge. Measurement of forniceal foreshortening facilitates monitoring of these disorders. This study aims (1) to define the limits of the normal human conjunctival fornices and how these alter with age and (2) to provide normative data for upper and lower fornix depths (FDs) and fornix intercanthal distance (FICD) within a healthy South Asian, racially distinct population.Design: Epidemiologic, cross-sectional study.Participants: A total of 240 subjects with national origins from South Asia, with no known ocular history and normal adnexal and conjunctival examination, aged 20 to 80 years.Methods: An FICD modification of a custom-designed fornix depth measurer (FDM) was validated and used for measurement of both lower and upper FDs together with FICDs in 480 healthy eyes with no ocular comorbidities. Data were analyzed using repeated-measures analysis of variance and presented as means with 95% confidence intervals (CIs).Main Outcome Measures: Mean lower and upper FDs and FICD for the entire cohort, stratified according to age decade and sex.Results: For this South Asian population, the overall upper and lower FDs were 15.3 mm (95% CI, 14.9–15.6) and 10.9 mm (95% CI, 10.7–11.1), respectively, with FICD defined as 32.9 mm (95% CI, 32.5–33.4) (upper) and 31.7 mm (95% CI, 31.3–32.1) (lower). With increasing age, a progressive reduction of all measured parameters (P < 0.001) was noted, with female subjects having significantly shallower fornices (upper FD, P < 0.001; lower FD, P < 0.001; upper FICD, P = 0.081; and lower FICD, P = 0.015).Conclusions: This is the first study to define the limits of normal upper FD and FICDs in any population group. Our study demonstrates sex variations and progressive conjunctival shrinkage with age. Although it provides important, objective data for normal forniceal anatomy, further study is recommended in other populations to confirm the generalizability of these data or to enable normal comparative datasets for the assessment of conjunctival scarring disorders among all anthropological groups.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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Driving Habits in Older Patients with Central Vision Loss – Corrected Proof

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Objective: To determine if central visual loss is associated with driving cessation, driving restriction, or other-driver preference.Design: Cross-sectional study.Participants: Sixty-four subjects with bilateral visual loss (<20/32 in better eye) or severe unilateral visual loss (<20/200) from age-related macular degeneration (AMD) and 58 normally sighted controls between 60 and 80 years of age.Methods: Participants self-reported driving habits. Other-driver preference was defined as preferring that another drive when there is more than 1 driver in the car. Subjects reporting 2 or more driving limitations were considered to have restricted their driving.Main Outcome Measures: Self-reported driving cessation, other-driver preference, and driving restriction.Results: Age-related macular degeneration subjects were older (74.7 vs. 69.7 years), had worse visual acuity (VA; mean better-eye VA, 0.43 vs. 0.08 logarithm of minimum angle of resolution [logMAR]) and contrast sensitivity (CS; 1.4 vs. 1.9 log units of CS [logCS]), and were more likely to be white when compared with controls (P < 0.001 for all). Drivers with AMD-related vision loss were more likely to avoid driving over longer distances, beyond 1 hour, at night, and in unfamiliar conditions (P < 0.05 for all). In multivariate models, driving cessation was associated with worse better-eye VA (odds ratio [OR], 1.5 per 1-line decrement in VA; P < 0.001) and worse binocular CS (OR, 1.36 per 0.1 logCS increment; P = 0.005); however, AMD group status was not associated with driving cessation (OR, 1.9; P = 0.35). Factors predicting driving restriction were AMD (OR, 9.0; P = 0.004), worse vision (OR, 2.5 per line of VA loss; P < 0.001), lower CS (OR, 2.2 per 0.1-logCS increment; P < 0.001), and female gender (OR, 27.9; P = 0.002). Other-driver preference was more common with worse vision (OR, 1.6 per 0.1-logMAR increment; P = 0.003), female gender (OR, 4.5; P = 0.02), and being married (OR, 3.8; P = 0.04).Conclusions: Most patients with AMD-related central vision loss continue to drive, but demonstrate significant driving restrictions, especially with more severe VA and CS loss. Future work should determine which driving adaptations the visually impaired best balance safety and independence.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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Genetic Susceptibility, Dietary Antioxidants, and Long-term Incidence of Age-related Macular Degeneration in Two Populations – Corrected Proof

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Objective: To examine effect modification between genetic susceptibility to age-related macular degeneration (AMD) and dietary antioxidant or fish consumption on AMD risk.Design: Pooled data analysis of population-based cohorts.Participants: Participants from the Blue Mountains Eye Study (BMES) and Rotterdam Study (RS).Methods: Dietary intakes of antioxidants (lutein/zeaxanthin [LZ], β-carotene, and vitamin C), long-chain omega-3 polyunsaturated fatty acids, and zinc were estimated from food frequency questionnaires. The AMD genetic risk was classified according to the number of risk alleles of CFH (rs1061170) or ARMS2 (rs10490924) as low (no or 1 risk allele) or high (≥2 risk alleles). Interactions between dietary intake and genetic risk levels were assessed. Associations between dietary intake and AMD risk were assessed comparing the highest with the 2 lower intake tertiles by genetic risk subgroups using discrete logistic regression, conducted in each study separately and then using pooled data. Participants without AMD lesions at any visit were controls. We adjusted for age and sex in analyses of each cohort sample and for smoking status and study site in pooled-data analyses.Main Outcome Measures: All 15-year incident late AMD cases were confirmed by chief investigators of the Beaver Dam Eye Study, BMES, and RS. Intergrader reproducibility was assessed in an early AMD subsample, with 86.4% agreement between BMES and RS graders, allowing for a 1-step difference on a 5-step AMD severity scale.Results: In pooled data analyses, we found significant interaction between AMD genetic risk status and LZ intake (P = 0.0009) but nonsignificant interactions between genetic risk status and weekly fish consumption (P = 0.05) for risk of any AMD. Among participants with high genetic risk, the highest intake tertile of LZ was associated with a >20% reduced risk of early AMD, and weekly consumption of fish was associated with a 40% reduced risk of late AMD. No similar association was evident among participants with low genetic risk. No interaction was detected between β-carotene or vitamin C and genetic risk status.Conclusions: Protection against AMD from greater LZ and fish consumption in persons with high genetic risk based on 2 major AMD genes raises the possibility of personalized preventive interventions.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

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