The purpose of this study is to test the safety of an investigational drug product, IBI-10090 (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery. DEXYCU was approved by the FDA in February 2018 for use in adults, however; has not yet been approved for use in children. The active ingredient in DEXYCU is dexamethasone. Instead of being an eye drop containing dexamethasone, DEXYCU remains in the eye as a tiny droplet and slowly releases dexamethasone over a period of approximately two to three weeks. After that time the droplet is absorbed by the body. Subjects 0 to 3 years of age who are undergoing cataract surgery will be eligible for this study. The study starts at screening visit which is 3-29 days before surgery. Any study-related procedures will be performed only after obtaining informed consent. Child will be in the study for about 90 days after signing informed consent. Enrollment in this study requires a total of 8 visits. If child is eligible he/she will be randomly assigned (like the flip of a coin) to either study group DEXYCU or control group, prednisolone acetate. Child will have study visits 1 day following cataract surgery, and then at approximately 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months after surgery. All visits are standard of care visits for all cataract surgery patients except 2 weeks and 6 weeks after surgery visits.
Many children experience signs and/or symptoms of inflammation after cataract surgery. If left untreated, inflammation generally resolves within 2 to 4 weeks after surgery; however, inflammation can lead to complications without treatment. Doctors commonly use drugs, called corticosteroids, that are like the study product to reduce inflammation and the pain and discomfort it causes following cataract surgery. The purpose of this study is to compare the effects of DEXTENZA® to a drug already on the market (prednisolone acetate suspension) in treating the inflammation in the eye after cataract surgery. DEXTENZA® is an insertion and prednisolone acetate suspension is delivered as an eye drop. It is believed that DEXTENZA® may provide potential benefits because it requires only a single application by the physician at the time of cataract surgery. Eye drops are typically applied several times a day for several weeks.
The purpose of this project is to identify the postoperative alignment of toric intraocular lenses (IOLs) in patients who have undergone cataract surgery.
The purpose of this study is to identify and measure refractive errors of the eye as well as visual symptoms after cataract surgery.
Older adults typically have trouble identifying the speech they hear, especially in noisy environments. Fortunately, compared to younger adults, older adults are better able to compensate for difficulties identifying the speech they hear by recruiting the visual system. However, the extent to which older adults can benefit from visual input, and how this influence relates to age-related changes in brain structure and function, have not been thoroughly investigated. The general purpose of this study is to determine how age-related changes in brain structure and function affect how well people hear and see. This study seeks participants with normal hearing to mild hearing loss, who also have normal or corrected-to-normal vision.
This study aims to create a database of people and families with hereditary retinal dystrophy in South Carolina. Patients with hereditary retinal dystrophy will be offered genetic analysis and counseling with the MUSC Center for Genomic Medicine and may donate cell samples for basic science research at the Department of Ophthalmology. This study will add to the research knowledge base of disease phenotype and epidemiology, and allow expansion of research to determine mechanism and potential therapy for inherited retinal disease
Intacs® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.
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.