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.
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.
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.
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)
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.
Ambylopia treatment study to compare the effectiveness of binocular game play versus patching in children ages 5 to < 17 years of age.
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.