A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION Save

Date Added
January 12th, 2016
PRO Number
Pro00039041
Researcher
Jan Kylstra
Keywords
Vision/ Eye
Summary

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.

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
December 8th, 2015
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

Validation of the Pediatric Sensory Modality Assessment and Rehabilitation Technique (SMART) 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 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.

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 Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth through Three Years Undergoing Unilateral Cataract Extraction with or without Lens Replacement. Save

Date Added
September 22nd, 2015
PRO Number
Pro00036624
Researcher
Marion Wilson
Keywords
Pediatrics, Vision/ Eye
Summary

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.

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

New Enrollment Post-Approval Study of the Argus (R) II Retinal Proshesis System Save

Date Added
April 28th, 2015
PRO Number
Pro00043355
Researcher
Luciano Del priore
Keywords
Vision/ Eye
Summary

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.

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

Treatment with the Argus II Retinal Prosthesis System a Humanitarian Use Device. Save

Date Added
April 21st, 2015
PRO Number
Pro00043514
Researcher
Luciano Del priore
Keywords
Vision/ Eye
Summary

The Argus II Humanitarian Use Device is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals

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

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