Publications by authors named "Michele Melia"

Article Synopsis
  • The study aims to evaluate how functional and structural assessments can serve as endpoints in clinical trials for retinal degeneration linked to USH2A mutations.
  • Participants with specific visual capabilities underwent various eye tests over four years, focusing on understanding changes in their vision.
  • Findings indicated that certain tests were more sensitive to detecting changes, influencing the design of future clinical trials related to this condition.
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Purpose: To evaluate the effect of diabetic retinopathy (DR) lesion type (hemorrhages and/or microaneurysms, intraretinal microvascular abnormalities, new vessels elsewhere, and venous beading), severity, and distribution on disease worsening based on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale.

Methods: Post hoc analysis of a multicenter observational study of 544 eyes with nonproliferative DR and an Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale score of Level 35 to 53. Disease worsening was defined as Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale worsening by ≥2 steps from baseline or receipt of DR treatment over 4 years.

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Purpose: To report the change in refractive error over 5 years after primary intraocular lens (IOL) placement by age at surgery and to identify factors associated with the change in refractive error after 5 years.

Design: Prospective observational study at 61 pediatric eye care practices.

Participants: One hundred eighty-six eyes of 152 children undergoing primary IOL implantation before 13 years of age for nontraumatic cataract.

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Article Synopsis
  • The study aimed to assess self-reported functional vision and the effects of vision loss in patients with USH2A-associated retinal degeneration using the Michigan Retinal Degeneration Questionnaire (MRDQ).
  • It involved 93 participants, with 55 having Usher Syndrome Type 2 (USH2) and 38 having autosomal recessive retinitis pigmentosa (ARRP), all linked to USH2A gene variants.
  • Results showed that MRDQ scores were sensitive to differences based on clinical diagnosis and other factors, and they correlated well with established visual function tests, highlighting the tool's effectiveness in evaluating vision-related functioning.
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Purpose: To describe functional vision (FV) and investigate the relationship between FV, visual acuity (VA), and hill of vision (V) at baseline in patients with biallelic USH2A variants.

Design: Multicenter, international, cross-sectional study.

Methods: In individuals with biallelic disease-causing variants in USH2A, clinical diagnosis of Usher syndrome type 2 (USH2) or autosomal recessive nonsyndromic retinitis pigmentosa (ARRP) was based on history of hearing loss and audiology examinations.

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Importance: Controlling myopia progression is of interest worldwide. Low-dose atropine eye drops have slowed progression in children in East Asia.

Objective: To compare atropine, 0.

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Significance: This pilot randomized trial, the first to evaluate a specific base-in relieving prism treatment strategy for childhood intermittent exotropia, did not support proceeding to a full-scale clinical trial. Defining and measuring prism adaptation in children with intermittent exotropia are challenging and need further study.

Purpose: This study aimed to determine whether to proceed to a full-scale trial of relieving base-in prism spectacles versus refractive correction alone for children with intermittent exotropia.

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Importance: Anti-vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) reduce development of vision-threatening complications from diabetes over at least 2 years, but whether this treatment has a longer-term benefit on visual acuity is unknown.

Objective: To compare the primary 4-year outcomes of visual acuity and rates of vision-threatening complications in eyes with moderate to severe NPDR treated with intravitreal aflibercept compared with sham. The primary 2-year analysis of this study has been reported.

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Background/purpose: To define "strong" versus "weak" antivascular endothelial growth factor (anti-VEGF) treatment response in eyes with center-involved diabetic macular edema (CI-DME).

Methods: Exploratory analyses of three DRCR Retina Network randomized trials of eyes with CI-DME treated with aflibercept, bevacizumab, or ranibizumab. Thresholds of 5-, 10-, and 15-letter gain defined strong visual acuity (VA) response when baseline VA was 20/25-20/32, 20/40-20/63, or 20/80-20/320, respectively.

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Importance: Presence of predominantly peripheral diabetic retinopathy (DR) lesions on ultra-widefield fluorescein angiography (UWF-FA) was associated with greater risk of DR worsening or treatment over 4 years. Whether baseline retinal nonperfusion assessment is additionally predictive of DR disease worsening is unclear.

Objective: To assess whether the extent and location of retinal nonperfusion identified on UWF-FA are associated with worsening in Diabetic Retinopathy Severity Scale (DRSS) score or DR treatment over time.

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Article Synopsis
  • Ultra-widefield (UWF) imaging is more effective at finding peripheral diabetic retinopathy (DR) lesions compared to standard imaging techniques, but it remains unclear if these lesions can predict worsening disease.
  • A cohort study involving 388 participants across 37 sites was conducted to investigate if predominantly peripheral lesions (PPLs) detected by UWF imaging are linked to an increased risk of disease worsening, beyond what is indicated by initial DR severity scores.
  • After analyzing data from 544 study eyes, findings showed that rates of disease worsening varied by the severity of nonproliferative diabetic retinopathy (NPDR), but the presence of color PPL at baseline did not significantly predict worsening outcomes.
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Significance: A rigorously designed and calibrated symptom questionnaire for childhood intermittent exotropia would be useful for clinical care and for research.

Purpose: The aim of this study was to Rasch-calibrate and evaluate the previously developed Child Intermittent Exotropia Symptom Questionnaire using data gathered as part of a randomized clinical trial.

Methods: The questionnaire was administered to 386 children aged 3 to 10 years with intermittent exotropia who were enrolled in a randomized clinical trial comparing overminus with nonoverminus spectacles.

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Purpose: Evaluate association of retinal nonperfusion (NP) on ultrawide field (UWF) fluorescein angiography (FA) with diabetic retinopathy (DR) severity and predominantly peripheral lesions (PPL).

Methods: Multicenter observational study, 652 eyes (361 participants) having nonproliferative DR (NPDR) without center-involved diabetic macular edema in at least one eye. Baseline 200° UWF-color and UWF-FA images were graded by a central reading center for color-PPL and FA-PPL, respectively.

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Purpose: To determine whether smartphone photographs of children's eyelids are reliable for diagnosing the presence of chalazia.

Methods: In this prospective cross-sectional study, 60 participants, 7 months to 16.5 years of age, at four sites were enrolled; all participants had a chalazion measuring at least 2 mm on at least one eyelid based on an in-person clinical examination by a pediatric eye care professional.

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Purpose: To measure visual fields using two-color dark-adapted chromatic perimetry in a subset of participants in the Rate of Progression of USH2A-related Retinal Degeneration (RUSH2A), a study of USH2A-mediated syndromic (USH2) and autosomal recessive nonsyndromic retinitis pigmentosa, determine percentage retaining rod function, and explore relationships between dark-adapted visual fields (DAVF) and rod function from ERG and full-field stimulus thresholds (FST).

Methods: Full-field rod mean sensitivity, number of rod loci, maximum sensitivity, DAVF full-field hill of vision (DAVF VTOT), and 30° hill of vision (DAVF V30) were measured in one eye for DAVF ancillary study participants (n = 49). Loci where cyan relative to red sensitivity was more than 5 dB on dark-adapted chromatic perimetry were considered rod mediated.

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Significance: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial.

Purpose: This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone.

Methods: Children (mean age, 5.

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Purpose: Develop equations to convert Cirrus central subfield thickness (CST) to Spectralis CST equivalents and vice versa in eyes with diabetic macular edema (DME).

Methods: The DRCR Retina Network Protocol O data were split randomly to train (70% sample) and validate (30% sample) conversion equations. Data from an independent study (CADME) also validated the equations.

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Importance: The follow-up schedule for individuals with eyes treated with anti-vascular endothelial growth factor agents for proliferative diabetic retinopathy (PDR) requires that patients return frequently for monitoring and repeated treatment. The likelihood that a patient will comply should be a consideration in choosing a treatment approach.

Objective: To describe completion of scheduled examinations among participants assigned to intravitreous injections of ranibizumab for PDR in a multicenter randomized clinical trial.

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Purpose: To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision.

Design: Phase 2 randomized clinical trial.

Participants: Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the United States.

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This study determines which of 8 doses of bevacizumab are effective in treating severe retinopathy of prematurity to carry forward to a large-scale randomized clinical trial.

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Purpose: To describe 2.5% low-contrast visual acuity (VA) among eyes with good vision despite center-involved diabetic macular edema and compare changes after initial management with aflibercept, laser, or observation.

Methods: This was an ancillary study within a multicenter randomized clinical trial (DRCR Retina Network Protocol V).

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