Status:
TERMINATED
Visual Enhancement Device in Low Vision Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Macular Degeneration, Age-Related
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20...
Detailed Description
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hou...
Eligibility Criteria
Inclusion
- Patient of any sex, race, or ethnicity who are 18 years of age or older. Spanish speaking patients will be encouraged to participate, Spanish forms will be available to review and execute.
- Patient willing to review, understand and sign written informed consent. Parents or legal guardians will consent on behalf of minors.
- Written authorization for use or release of health and research study information.
- Patient who volunteers is suffering from a posterior segment ophthalmic disorder including AMD and/or Diabetic Retinopathy and visual acuity from 20/60 to 20/400 in the better seeing eye.
Exclusion
- Subjects will be excluded if they are less than 18 years of age.
- Subjects will not be considered for this research study if they will not review and execute the informed consent form.
- During the screening process, subjects will be excluded from further consideration if they are identified with having a potential ophthalmic diagnosis other than age-related macular degeneration or diabetic macular edema that could be negatively affecting the visual testing.
- ETDRS Visual Acuity better than 20/60 or worse than 20/400
- During screening, subjects will be disqualified from further assessment if it is determined that their refractive error is outside of the -5.00 to +5.00 D corrective range.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03794752
Start Date
February 1 2015
End Date
December 28 2018
Last Update
January 5 2021
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