Low Vision Aids Clinical Trial
Official title:
Utility and Efficacy of Tactile Labeling of Ophthalmic Drops for Identity and Frequency of Administration in Low Vision
NCT number | NCT04483882 |
Other study ID # | 20-0087 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 24, 2020 |
Est. completion date | December 15, 2021 |
Verified date | April 2021 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 UTMB Maker Space to improve low vision patients capability to identify their topical ophthalmic drop treatments and the frequency with which they should be administered. The labeling strategy includes protrusions as frequency markers and shapes to differentiate between treatments of similar frequency prescription.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 15, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | IInclusion Criteria: 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:Inclusion Criteria: - 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 Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Medical Branch, Ophthalmology Clinical Research Center | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correct Drug Identity by Shape | Subjects Assessment and Report of drug identity by shape of label protrusions | 2 minutes | |
Primary | Correct Drug Identity by Color | Subject Assessment and Report of drug identity by color of tactile label | 2 minutes | |
Primary | Correct Dose Frequency by Tactile Protrusions | Subject Assessment and Report of Drug Dosing frequency by number of protrusions of tactile label | 2 minutes |
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