A Randomized, Parallel-arm, Active Control, Multicenter Study Assessing the Safety and Efficacy of Dextenza for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Date Added
August 25th, 2020
PRO Number
Pro00100918
Researcher
Marion Wilson

List of Studies


Keywords
Pediatrics, Vision/ Eye
Summary

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.

Institution
MUSC
Recruitment Contact
Carol Bradham
8437926301
bradhamc@musc.edu

A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children

Date Added
January 28th, 2020
PRO Number
Pro00095033
Researcher
Mae Peterseim

List of Studies


Keywords
Vision/ Eye
Summary

Myopia usually worsens during childhood. High myopia is associated with retinal detachments and other serious eye conditions causing poor vision. In this study, eye drops of two concentrations of dilute atropine or placebo will be administered daily to children with myopia, ages 3-14 years, over a 4 year period. It is hoped that the dilute atropine drops will slow the worsening of myopia compared to other treatments. The purpose of this study is to determine and compare these drugs' efficacy in reducing the progression of myopia.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Integrated Analysis of Toric Intra-Ocular Lens Rotation with Ray-Tracing Aberrometry

Date Added
March 4th, 2019
PRO Number
Pro00081873
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this project is to identify the postoperative alignment of toric intraocular lenses (IOLs) in patients who have undergone cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Integrated Analysis of Vision Quality with Aberrometry

Date Added
March 27th, 2018
PRO Number
Pro00074857
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to identify and measure refractive errors of the eye as well as visual symptoms after cataract surgery.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Neural Determinants of Age-Related Change in Auditory-Visual Speech Processing

Date Added
September 24th, 2017
PRO Number
Pro00070971
Researcher
James Dias

List of Studies


Keywords
Aging, Brain, Central Nervous System, Ears, Healthy Volunteer Studies, Hearing, Language, Minorities, Vision/ Eye
Summary

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.

Institution
MUSC
Recruitment Contact
James Dias
(843) 792-3921
diasj@musc.edu

Characterizing Hereditary Retinal Dystrophy within South Carolina

Date Added
August 15th, 2017
PRO Number
Pro00065234
Researcher
Mae Peterseim

List of Studies


Keywords
Vision/ Eye
Summary

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

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Intacs Inserts-Prescription Inserts for Treatment of Patients with Keratoconus (HDE)

Date Added
November 17th, 2015
PRO Number
Pro00046816
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

Intacs® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts

Date Added
October 27th, 2015
PRO Number
Pro00049105
Researcher
Marion Wilson

List of Studies


Keywords
Vision/ Eye
Summary

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)

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

A PROSPECTIVE OBSERVATIONAL ANALYSIS OF NEAR VISION IN MONOFOCAL PSEUDOPHAKIC CHILDREN

Date Added
August 12th, 2015
PRO Number
Pro00037499
Researcher
Marion Wilson

List of Studies


Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

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.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Analysis of genetic variant and treatment based variations in infants at risk for retinopathy of prematurity (ROP)

Date Added
July 31st, 2015
PRO Number
Pro00041164
Researcher
Lakshmi Katikaneni

List of Studies


Keywords
Children's Health, Genetics, Infant, Vision/ Eye
Summary

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.

Institution
MUSC
Recruitment Contact
Kinsey Shirer
843-792-2799
evanssa@musc.edu



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