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

Determination of the effectiveness of a new way to measure the potential acuity of patients as compared to traditional potential acuity meter and post-surgical Snellen acuity Save

Date Added
April 15th, 2015
PRO Number
Pro00016836
Researcher
Elizabeth Richter
Keywords
Vision/ Eye
Summary

This study is intended to compare the accuracy of the visual acuity measurement done with a new projected eyechart method when compared to the gold standard (Marco Guyton-Minkowski PAM) before surgery and Snellen wallchart acuity after cataract surgery.

Institution
MUSC
Recruitment Contact
Elizabeth Richter
843-792-8100
brichter@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

Cell Modeling of Human Retinal Degenerations: Insights using Patient-Specific Human Induced-Pluripotent Stem Cells (iPSCs) Save

Date Added
March 17th, 2015
PRO Number
Pro00023262
Researcher
Mark Fields
Keywords
Aging, Rehabilitation Studies, Vision/ Eye
Summary

The purpose of this study will be to collect a skin biopsy (skin tissue) or blood sample from each participating patient with retinal degeneration, such as Best’s disease or age-related macular degeneration (AMD), including geographic atrophy (GA). Each skin biopsy or blood sample will be taken to the laboratory of the investigators where skin epithelial cells called fibroblasts, will be induced to make “pluripotent stem cells” or “iPSCs”. These iPSCs will be differentiated into retina epithelial cells which will be tested for their ability to function as new retinal cells in animal models of retinal degeneration. Because these special cells are individualized or patient-specific, they will not be rejected by that individual patient, and thereby represent the first step in a potential future treatment for retinal disease. Cells will also be processed at the New York Stem Cell Foundation IPSC core facility using the procedure described above. The Medical University of South Carolina (MUSC) and New York Stem Cell Foundation (NYSCF) will enter into a material transfer agreement (MTA) initiated by the MUSC Foundation for Research Development. Once MTAs are initiated, samples will be coded at MUSC. Coded samples will be sent via dry ice to ensure full competency to the NYSCF. Samples will remain coded at MUSC and will not be released to the NYSCF. Fibroblasts will be reprogrammed using the method described above and sent back to MUSC (as iPS cells) for the research purposes of this study. Cells will only be identifiable to the NYSCF by disease, sex, and gender. Once cells are received by the NYSCF they receive a number bar code for further processing and are in no way traceable to the patient by the NYSCF. Reprogrammed cells will be stored at the NYSCF biorepository but only shared with the knowledge of MUSC. These samples will be used for the purposes of this study. Any other use will be evaluated by the investigators and the MUSC Foundation for Research Development and the appropriate action taken. Once samples are processed that will not be withdrawn from the biorepository. The NYSCF biorepository is a secure facility with only authorized personnel having access to the facility

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

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 13th, 2015
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
January 13th, 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

A Phase 3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Save

Date Added
December 9th, 2014
PRO Number
Pro00039325
Researcher
Isabel Virella-lowell
Keywords
Lung, Pediatrics, Pulmonary, Stage III, Vision/ Eye
Summary

Children aged 6-11-years-old with Cystic Fibrosis who are homozygous for the F508del-CFTR are welcome to volunteer for this study.

This study is being done to learn more about the safety and tolerability of taking lumacaftor with ivacaftor.

Ivacaftor, at a different dose, is approved for some patients aged 6 and older in the US and certain other countries. Ivacaftor is marketed in the US under the trade name Kalydeco. Ivacaftor is experimental in patients with CF that are homozygous for the F508del CFTR mutation.

Institution
MUSC
Recruitment Contact
Elizabeth Poindexter
843-792-1820
poindex@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
October 14th, 2014
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

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

Evaluation of vision screening with Pediavision Plus-Optix vision screening Save

Date Added
April 7th, 2010
IRB Number
19837
Researcher
M. Peterseim
Keywords
Vision/ Eye
Summary

We are recruiting approximately 100 pediatric patients ages 2-12 within the Storm Eye Institute's pediatric clinics to compare findings of the Pediavision plus optix vision screener to the findings of a pediatric ophthalmologic exam and evaluate its efficacy.

Institution
MUSC
Recruitment Contact
Dr. Mae Peterseim
843-792-2608
peterseim@musc.edu

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