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 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.
The purpose of this study is to understand better how many people who have been diagnosed with early-onset idiopathic bilateral cataracts may have a rare but treatable disease called Cerebrotendinous Xanthomatosis (CTX)
This research study will test whether or not using an investigational drug called OMS302 during pediatric cataract surgery helps keep the pupil dilated (open) and reduces eye pain after surgery. OMS302 (Omidria™ phenylephrine and ketorolac injection 1%/0.3%) has been approved by United States Food and Drug Administration for use in adults to keep the pupil dilated during surgery and reduce eye pain after the surgery. The use of Omidria™ in children has not been FDA-approved. This study is being done to help gain FDA approval for this drug?s use during cataract surgeries on children up to 3 years old.
We propose a prospective observational analysis of near visual acuity and stereopsis in pseudophakic children. Visual acuity analysis will be standardized based on age per PEDIG protocols. Results will be stratified by age and by monocular versus binocular surgery. Children will be assessed in their appropriate corrective lenses to control for myopia as a confounding factor. Refractive error will be measured to optimize visual acuity measurement and assess for the potential role of astigmatism in preservation of near visual function.
Infants born early who are in the neonatal intensive care unit will be included if they meet national guidelines for retinopathy of prematurity (ROP) screening exams. Informed consent will be given to the parent(s) or legal guardians. 1.5-2 ml of blood will be drawn from a vein when the child is enrolled in the study and may be drawn again if the child requires treatment of eye disease. A cheek swab will also be obtained. These biologic samples will be shipped overnight to the University of Utah for genetic analysis. Analysis will determine if a change in gene expression causes retinopathy of prematurity. Infants enrolled in the study will be followed clinically per established ROP screening guidelines. They will not require additional study exams.
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