A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Efficacy and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 in Patients with Presbyopia Save

Date Added
February 14th, 2017
PRO Number
Pro00062335
Researcher
Karolinne Rocha
Keywords
Vision/ Eye
Summary

The purpose of this study is to investigate the safety, effectiveness, tolerability of different combinations of two drugs for the potential treatment of Presbyopia. Presbyopia is a normal aging process where there is a gradual loss of the eyes' ability to see up close.

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

A Randomized Clinical Trial of Overminus Spectacle Therapy For Intermittent Exotropia (IXT5) Save

Date Added
January 17th, 2017
PRO Number
Pro00062434
Researcher
Edward Cheeseman
Keywords
Vision/ Eye
Summary

The purpose of this study is to find help for intermittent exotropia (eyes that drift) by using overminus glasses (glasses that are intentionally stronger).

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

A Phase 3, Multi-Center Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery. Save

Date Added
October 25th, 2016
PRO Number
Pro00057963
Researcher
Karolinne Rocha
Keywords
Vision/ Eye
Summary

The purpose of this study is to determine the effectiveness and safety of LE ophthalmic gel 0.38% compared with placebo in treating eye inflammation and pain after cataract surgery.
This research will take place at the MUSC Storm Eye Institute. The study last approximately 30 days with 7 visits, each lasting approximately 1 hour each.
Participants must be 18 years or older and be a candidate for routine, uncomplicated cataract surgery.

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

A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients with Non-Infectious Anterior Segment Uveitis Save

Date Added
September 13th, 2016
PRO Number
Pro00058667
Researcher
Lynn Perry
Keywords
Vision/ Eye
Summary

This study is using an investigational drug delivery system that is placed on the eye which generates a mild electric current which helps deliver study drug or placebo (depending on which group the patient is randomized) to the eye that has been diagnosed with uveitis

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

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

Change_preferences

-- OR --

Create_login