Growth and Retinopathy of Prematurity Registry Save

Date Added
April 26th, 2016
PRO Number
Pro00053408
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

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.

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

A PHASE II, MULTICENTER, RANDOMIZED, ACTIVE TREATMENT?CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF THE RANIBIZUMAB PORT DELIVERY SYSTEM FOR SUSTAINED DELIVERY OF RANIBIZUMAB IN PATIENTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION Save

Date Added
April 1st, 2016
PRO Number
Pro00043506
Researcher
W. lloyd Clark
Keywords
Vision/ Eye
Summary

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.

Institution
Palmetto
Recruitment Contact
Tiffany Swinford
803-404-5037
tswinford@palmettoretina.com

Validation of the Pediatric Awareness and Sensory Motor Assessment (PASMA) Save

Date Added
December 1st, 2015
PRO Number
Pro00048514
Researcher
Cynthia Dodds
Keywords
Brain, Children's Health, Hearing, Vision/ Eye
Summary

The purpose of this project is to study validity of a newly developed pediatric tool, the Pediatric Awareness and Sensory Motor Assessment (PASMA), 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 HMS School in Philadelphia, PA, 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 PASMA 5 times within 10 days. The PASMA 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 PASMA 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 PASMA validity. Once validity has been substantiated for the PASMA by means of further study, future children with severe brain injury, being evaluated with the PASMA, may have rehabilitation and treatments opportunities that are better informed, leading to greater improvement in functional and participatory outcomes.

Institution
MUSC
Recruitment Contact
Cynthia Dodds
843-792-5731
doddscb@musc.edu

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

Date Added
November 17th, 2015
PRO Number
Pro00046816
Researcher
George Waring iv
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 Save

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

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

Date Added
July 31st, 2015
PRO Number
Pro00041164
Researcher
Richard Saunders
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

Amblyopia Treatment Study (ATS18) Study of Binocular Computer Activities for Treatment of Amblyopia Save

Date Added
March 17th, 2015
PRO Number
Pro00041906
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

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

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

Long Term Safety Follow-up for Subjects Previously Implanted with the the AcrySof® Cachet™ Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57 Save

Date Added
February 14th, 2012
PRO Number
Pro00014945
Researcher
Matthew Nutaitis
Keywords
Vision/ Eye
Summary

This study will gather long-term data to better understand the safety of the ACRYSOF® Cachet™ Phakic Lens.

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

INTERMITTENT EXOTROPIA STUDY 1 (IXT1) A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia Save

Date Added
February 2nd, 2011
IRB Number
20190
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

This research is being done with children who have a condition called intermittent exotropia. Intermittent exotropia is the medical term used when the eyes turn out some of the time and are straight at other times. Intermittent exotropia is one of the most common types of eye misalignment in children.

Intermittent exotropia is often treated with surgery on the eye muscles to make the eyes straight again. There are different ways to do this surgery to straighten the eyes. One way is to operate on two muscles on one eye. Another way is to operate on one muscle on each eye. Both ways of doing the surgery work well but we do not know if one way is better than the other. This is the reason why the study is being done.

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

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