Clinical trial NCT04483882: Tactile Low Vision Labeling of Ophthalmic Drops
Official title: Utility and Efficacy of Tactile Labeling of Ophthalmic Drops for Identity and Frequency of Administration in Low Vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision Aids
Keywords: Low Vision, Labeling, Tactile
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single Group, Blinded, Sham controlled study
Primary purpose: OTHER

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correct Drug Identity by Shape
timeFrame: 2 minutes
measure: Correct Drug Identity by Color
timeFrame: 2 minutes
measure: Correct Dose Frequency by Tactile Protrusions
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Ophthalmology Clinical Research Center
state: Texas
Study officials:
affiliation: University of Texas
name: Praveena Gupta, O.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: