Tactile Low Vision Labeling of Ophthalmic Drops

  • STATUS
    Recruiting
  • participants needed
    92
  • sponsor
    The University of Texas Medical Branch, Galveston
Updated on 19 February 2024

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 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.

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 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.

The first aim is to evaluate the patient capability to identify the number of protrusions and therefore the frequency of administration prescribed. This should be completed in a timeframe that is not frustrating or problematic to the patient in practice.

The second aim is to evaluate the patient ability to differentiate between drugs with similar frequencies based on a shape on the frequency protrusions in a tactile manner. This also should be completed in a timeframe that is not over burdensome or frustrating to the patient. The protocol is designed to evaluate this tactile labeling design in the population it is designed to support.

Details
Condition Low Vision Aids
Age 18years - 100years
Treatment Tactile Labels for Drug identity and dose frequency
Clinical Study IdentifierNCT04483882
SponsorThe University of Texas Medical Branch, Galveston
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion 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
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