Studies within the Center for Preventive Ophthalmology and Biostatistics
The CPOB is home to several multi-center clinical trials, serving in the capacity of the Data Coordinating Center. For each trial, a multi-disciplinary team of professionals is assembled to provide the required expertise.
Click on the links below to learn more about CPOB Studies.
Ongoing Studies
Ongoing Studies in the CPOB include:
- Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked randomized clinical trial. The purpose of this study is to compare glaucoma drainage device (GDD) implantation with the drainage tube placed in the anterior chamber or the sulcus in efforts to minimize corneal cell loss in the eye.
- The Identification of School-age Eye problems Evaluation (ISEE) program is a multi-center, multidisciplinary study to compare the effectiveness of vision screening using both traditional and technology/instrument-based tests for identification of school-age children at risk for significant vision problems (SVP) and in need of an eye exam.
- FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a randomized, double-masked, placebo controlled clinical trial that is funded by the National Eye Institute. The study is designed to assess the efficacy and safety of fluorometholone vs. placebo eyedrops as ancillary therapy for patients in Ethiopia with trachomatous trichiasis (TT) who are undergoing lid rotation/correction surgery.
Completed Studies
Completed multi-center studies led by CPOB:
- DRy Eye And Management (DREAM) Study is a multi-center, double masked randomized clinical trial that is funded by the National Eye Institute to evaluate the efficacy and safety of omega 3 fatty acids (fish oil) compared to placebo in patients with mild to moderate dry eye disease (DED).
- The Postnatal Growth and Retinopathy of Prematurity (G-ROP) Studies are two large-scale multi-center studies, sponsored by the National Eye Institute, to develop a ROP prediction model on a retrospective cohort (n=7,483) and validate the prediction model on a prospective cohort (n=4,393) using postnatal weight gain to identify infants with severe ROP.
- The Comparison of Age-related Macular Degeneration Treatments Trials (CATT) are a set of multicenter, randomized clinical trials of treatments for neovascular age-related macular degeneration (AMD), the leading cause of blindness in the United States. The Lucentis-Avastin Trial, supported by the National Eye Institute, will be the first CATT clinical trial.
- Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (e-ROP) Study is a multi-center study designed to evaluate the validity, reliability, feasibility and cost-effectiveness of a telemedicine system to detect eyes of at-risk babies in need of a diagnostic examination by an ophthalmologist experienced in retinopathy of prematurity (ROP). The study is funded by the National Eye Institute of NIH.
- Retinopathy in Chronic Renal Insufficiency (RCRIC) Study is is a multi-centered research study that will investigate the effect that chronic kidney disease has on the eyes. The study involves photographing the retinas of people with chronic kidney disease. The information gathered from the photos will help researchers better understand the relationship between kidney disease, heart disease, and eye conditions. CPOB serves as both the Coordinating Center and Reading Center for the RCRIC study, which is funded by the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK).
- Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study is a randomized clinical trial designed to evaluate the safety and provide a preliminary assessment of the effectiveness of a new drug used with a new drug delivery system to treat patients with anterior scleritis. The sponsors of this study are the United States Food and Drug Administration (FDA), which is an agency that is part of the federal government, and EyeGate Pharmaceuticals, Inc. (EyeGate).
- Complications of Immunosuppressive Therapy for Eye Diseases Cohort (SITE) Study is a multicenter study of approximately 8,000 patients with inflammatory eye diseases followed retrospectively for up to 25 years for mortality (death), using the National Death Index. The study is funded by the National Eye Institute.
- The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) is an NEI-sponsored, randomized, clinical trial involving 23 clinical centers nationwide, 1000 patients, and an annual budget of $3 million. The trial is evaluating laser treatment among patients at high risk of developing severe loss of vision from age-related macular degeneration, the leading cause of blindness in the United States and many other western countries. The CPOB serves as both the CAPT Coordinating Center and the CAPT Fundus Photograph Reading Center.
- Vision in Preschoolers (VIP) Study is an NEI-sponsored multicenter study to evaluate the accuracy of traditional and newly developed screening tests for detecting amblyopia, strabismus, and significant refractive error in preschool children. Through a series of evaluation cycles, nearly 10,000 children will be tested through 5 clinical centers nationwide over a period of 5 to 6 years. The CPOB serves as the Coordinating Center for the VIP study.
- The GALA Study is a multi-center, double masked randomized clinical trial that will evaluate alpha lipoic acid (ALA) as a potential treatment for geographic atrophy (GA) due to age related macular degeneration (AMD). It is funded by the BrightFocus Foundation, Cures Within Reach, and the Pennsylvania Lions.
- The Multicenter Uveitis Steroid Treatment (MUST) Trial is a randomized clinical trial that compares an intraocular corticosteroid implant to standard oral therapy for the treatment of patients with severe, vision-threatening uveitis.
- The Choroidal Neovascularization Prevention Trial (CNVPT; 1994-2000), sponsored in part by the National Eye Institute (NEI) was a pilot randomized trial of laser photocoagulation in eyes at high risk of choroidal neovascularization secondary to age-related macular degeneration. The CNVPT included 276 patients, 15 clinical centers, and resulted in 6 peer-reviewed publications. THE CNVPT was the pilot study for the CAPT Study.
- Age-Related Macular Degeneration Radiotherapy Trial (AMDRT;2000-2003): CPOB staff served as the Coordinating Center for the AMDRT, an NEI sponsored pilot study to evaluate the safety and feasibility of conducting a large-scale trial of radiotherapy for eyes with neovascular AMD. The AMDRT included 88 patients, 10 clinical centers and resulted in 3 publications.
- IDx-DR
- (VIP-HIP)