Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration

Purpose To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. Design Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). Methods Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. Results Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. Conclusions The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses

White paper on ophthalmic imaging for choroidal nevus identification and transformation into Melanoma

Purpose: To discuss the evolution of noninvasive diagnostic methods in the identification of choroidal nevus and determination of risk factors for malignant transformation as well as introduce the novel role that artificial intelligence (AI) can play in the diagnostic process. Methods: White paper. Results: Longstanding diagnostic methods to stratify benign choroidal nevus from choroidal melanoma and to further determine the risk for nevus transformation into melanoma have been dependent on recognition of key clinical features by ophthalmic examination. These risk factors have been derived from multiple large cohort research studies over the past several decades and have garnered widespread use throughout the world. More recent publications have applied ocular diagnostic testing (fundus photog-raphy, ultrasound examination, autofluorescence, and optical coherence tomography) to identify risk factors for the malignant transformation of choroidal nevus based on multimodal imaging features. The widespread usage of ophthalmic imaging systems to identify and follow choroidal nevus, in conjunction with the characterization of malignant transformation risk factors via diagnostic imaging, presents a novel path to apply AI. Conclusions: AI applied to existing ophthalmic imaging systems could be used for both identification of choroidal nevus and as a tool to aid in earlier detection of transformation to malignant melanoma. Translational Relevance: Advances in AI models applied to ophthalmic imaging systems have the potential to improve patient care, because earlier detection and treatment of melanoma has been proven to improve long-term clinical outcomes

Herpes simplex virus type 2 mediated acute retinal necrosis in a pediatric population: case series and review

We report 15 eyes with herpes simples virus type 2 (HSV-2) mediated acute retinal necrosis (ARN) in order to better characterize pathogenesis, clinical course, diagnosis, and outcomes of the disease. Retrospective observational case series of 14 patients (15 eyes) all aged 21 years or younger with acute retinal necrosis resulting from HSV-2 and examined between 1995 and 2009. Patients were diagnosed by various techniques, including polymerase chain reaction (PCR) of aqueous, vitreous, and serum, antibody determination of serum and intraocular fluids, fundoscopic exam, a therapeutic trial of antivirals active against HSV-2, or a combination thereof. Mean age of presentation was 11.7 years (range, newborn to 21.0 years) with a standard deviation of 7.0 years. Mean initial vision was 20/200 (median, 20/400; range, 20/20 to LP). Eleven patients (73.3 %) had received oral, injectable, or topical corticosteroids, and 14 (93.3 %) had received antiviral therapy. All patients were diagnosed based on evaluation of intraocular fluids and tissue by antibody determinations, culture, PCR, histopathologic examination, or a combination thereof. Mean final visual acuity was 20/400 (median, CF; range, 20/25 to LP) with worsened visual acuity in five eyes (33.3 %). Anatomically, 14 of 15 eyes had healed or improved retinal appearance. In a pediatric population with acute retinal necrosis, HSV-2 should be considered as the prime candidate virus. Diagnosis of HSV-2 acute retinal necrosis is accomplished mainly by PCR of ocular specimens. Prompt diagnosis may lead to appropriate anti-viral therapy

Treatment of Massive Subretinal Hemorrhage From Complications of Scleral Buckling Procedures

Vitrectomy techniques permit removal of subretinal hemorrhage, but the prognosis varies and depends principally on the cause of the hemorrhage. Nine consecutive patients undergoing pars plana vitrectomy with internal drainage of massive subretinal hemorrhage from complications of scleral buckling procedures were studied, to evaluate the long-term results. In all eyes, the final visual acuity was improved, compared with preoperative visual acuity, and was 20/80 or better in seven of nine cases. Recurrent retinal detachment secondary to proliferative vitreoretinopathy developed in two patients, but complete retinal reattachment was achieved after further procedures were performed. Patients with massive subretinal hemorrhage from complications of scleral buckling procedures comprise a subgroup of patients with subretinal hemorrhage in which internal drainage via pars plana vitrectomy is an acceptable alternative to observation only and may result in improved visual acuity outcomes

Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

Objective: To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Design: Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. Participants: We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. Methods: At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 mu m. Main Outcome Measures: The primary outcome for the open-label extension was safety; BCVA was also evaluated. Results: At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a >= 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A >= 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Conclusions: Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2011; 118: 2453-2460 (C) 2011 by the American Academy of Ophthalmology

Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

Objective: To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO).Design: Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension.Participants: We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO.Methods: At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 mu m.Main Outcome Measures: the primary outcome for the open-label extension was safety; BCVA was also evaluated.Results: At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. in the group receiving two 0.7-mg DEX implants (n = 341), a >= 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). the IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A >= 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively.Conclusions: Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. in patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2011; 118: 2453-2460 (C) 2011 by the American Academy of Ophthalmology.Allergan, Inc.AllerganAllergan, NovartisAlimera, Allergan, Genentech, RegeneronAlcon, Allergan, BayerWills Eye Inst, Philadelphia, PA 19107 USAUniv Vita Salute, Hosp San Raffaele, Milan, ItalyUniversidade Federal de São Paulo, Vis Inst, São Paulo, BrazilStanford Univ, Stanford, CA 94305 USAUniv Sydney, Sydney, NSW 2006, AustraliaOphthalm Consultants Boston, Boston, MA USATel Aviv Med Ctr & Sch Med, Tel Aviv, IsraelAsan Med Ctr, Seoul, South KoreaAllergan Pharmaceut Inc, Irvine, CA USAUniversidade Federal de São Paulo, Vis Inst, São Paulo, BrazilWeb of Scienc

The Acute Retinal Necrosis Syndrome

The acute retinal necrosis syndrome is characterized by necrotizing retinitis, vitritis, and retinal vasculitis occurring in otherwise healthy patients. Experience with 11 cases and the review of 30 additional cases in the literature are presented. In this series, 50% of the affected eyes developed retinal detachments, and 64% had a final visual acuity of less than 20/200. The natural history, diagnosis, postulated etiology, and suggestions for management will be discussed

Defining a minimum set of standardized patient-centered outcome measures for macular degeneration

PURPOSE: To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses

Verteporfin therapy of subfoveal choroidal neovascularization in patients with age-related macular degeneration - Additional information regarding baseline lesion composition's impact on vision outcomes - TAP report No. 3

To explore how baseline lesion composition influenced vision outcomes in patients with age-related macular degeneration (AMD) undergoing photodynamic therapy with verteporfin (Visudyne) for subfoveal choroidal neovascularization (CNV) in the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy Investigation