Status:
COMPLETED
Tactile Low Vision Labeling of Ophthalmic Drops
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Low Vision Aids
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The purpose of this study is an evaluation of a tactile labeling strategy developed in the Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in collaboration with the...
Detailed Description
The purpose of this study is an evaluation of a tactile labeling strategy developed in the Ophthalmology Clinical Research Center at University of Texas Medical Branch (UTMB) in collaboration with the...
Eligibility Criteria
Inclusion
- I
- Phase I:
- Candidates will be healthy adults between 18 and 100 years of age
- Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
- Phase II:
- Candidates will be between 50 and 100 years of age.
- Candidates will have a BCVA equal to or less than 20/70 or have central vision field less than 20 degrees.
- Candidates will complete the consent briefing and consent documents prior to participating in any study activities.
Exclusion
- Phase I:
- Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
- History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
- Phase II;
- Candidates under 50 years or older than 100 years of age will be excluded.
- Candidates with a BCVA better than 20/70 or have central vision field greater than 20 degrees, will be excluded.
- Candidates with comorbidities that in the opinion of the investigator confound their ability to complete the assessments in this study (ie. Advanced neuropathy of the hands, dementia, or mental incapacity) will be excluded.
- Candidates who do not complete the consent briefing and indicate consent through completion of consent documents with or without a witness (as indicated by their ability to read the documents for themselves out loud with whatever optical assistance necessary (large print, magnification, optical correction, etc.), prior to any study activity, will not be included in this study.
- History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04483882
Start Date
July 24 2020
End Date
December 15 2021
Last Update
December 23 2021
Active Locations (1)
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1
University of Texas Medical Branch, Ophthalmology Clinical Research Center
Galveston, Texas, United States, 77555