The purpose of the registry is to provide a mechanism to store clinical data to support future research about postnatal weight gain based risk prediction for severe ROP and secondarily severe ROP and ROP treatment rates. If validated, the predictive model would eventually replace current ROP screening guidelines in determining the necessity and timing of ROP examinations for premature infants.
The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with retinitis pigmentosa. This is a post-market study gathering safety data and evaluate measures of visiual function to ensure that the risks ad benefits of the device continue to be acceptable (post FDA approval). Data gathered during this study may aso contribute to improvements to the device.
The Argus II Humanitarian Use Device is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals
Study GX28228 is a Phase II, multicenter, randomized, active treatment (monthly ITV injection)?controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in patients with subfoveal neovascular (wet) AMD. The study will also evaluate the safety of the RPDS combination product.
Ambylopia treatment study to compare the effectiveness of binocular game play versus patching in children ages 5 to < 17 years of age.
The purpose of this study will be to collect a skin biopsy (skin tissue) or blood sample from each participating patient with retinal degeneration, such as Best?s disease or age-related macular degeneration (AMD), including geographic atrophy (GA). Each skin biopsy or blood sample will be taken to the laboratory of the investigators where skin epithelial cells called fibroblasts, will be induced to make ?pluripotent stem cells? or ?iPSCs?. These iPSCs will be differentiated into retina epithelial cells which will be tested for their ability to function as new retinal cells in animal models of retinal degeneration. Because these special cells are individualized or patient-specific, they will not be rejected by that individual patient, and thereby represent the first step in a potential future treatment for retinal disease. Cells will also be processed at the New York Stem Cell Foundation IPSC core facility using the procedure described above. The Medical University of South Carolina (MUSC) and New York Stem Cell Foundation (NYSCF) will enter into a material transfer agreement (MTA) initiated by the MUSC Foundation for Research Development. Once MTAs are initiated, samples will be coded at MUSC. Coded samples will be sent via dry ice to ensure full competency to the NYSCF. Samples will remain coded at MUSC and will not be released to the NYSCF. Fibroblasts will be reprogrammed using the method described above and sent back to MUSC (as iPS cells) for the research purposes of this study. Cells will only be identifiable to the NYSCF by disease, sex, and gender. Once cells are received by the NYSCF they receive a number bar code for further processing and are in no way traceable to the patient by the NYSCF. Reprogrammed cells will be stored at the NYSCF biorepository but only shared with the knowledge of MUSC. These samples will be used for the purposes of this study. Any other use will be evaluated by the investigators and the MUSC Foundation for Research Development and the appropriate action taken. Once samples are processed that will not be withdrawn from the biorepository. The NYSCF biorepository is a secure facility with only authorized personnel having access to the facility
This study is to compare the effect of an investigational drug (Lampalizumab) in an injection to the eye every 4 to 6 weeks compared to a sham (false ) injection on the effects of Geographic Atrophy secondary to patients with Age Related Macular Degeneration. This study will last for 2 years. The study will involve blood draws and numerous ophthalmic exams.
The purpose of this project is to study validity of a newly developed pediatric tool, the Pediatric Sensory Modality Assessment and Rehabilitation Techniques (SMART), which will measure cognitive awareness for children with severe brain damage. Thirty children, between the ages of 3-21 years, with physician-documented severe brain damage and considered medically stable are needed for this study. Recruitment flyers will be disseminated at iHope (school serving children with severe disabilities) in NY, NY, MUSC and the greater Charleston area community to recruit parents/legal guardians of children with severe brain damage. Once parental/legal guardian and physician consents are in place, participants will be evaluated using the Pediatric SMART 5 times within 10 days. The Pediatric SMART is made up of 5 domains that are olfactory, visual, auditory and vestibular, gustatory, and tactile. Test administration requires approximately 1 hour and can be completed in settings convenient for parents/legal guardians. The potential benefit to study participants is that the findings from the Pediatric SMART may identify sensory and motor strengths of participants. Knowledge of these strengths may enhance current rehabilitation and treatment plans, which may lead to functional improvements; although, this cannot be guaranteed. It is a goal of this study to evaluate Pediatric SMART validity. Once validity has been substantiated for the Pediatric SMART by means of further study, future children with severe brain injury, being evaluated with the Pediatric SMART, may have rehabilitation and treatments opportunities that are better informed, leading to greater improvement in functional and participatory outcomes.
Intacs® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.