Tactile Low Vision Labeling of Ophthalmic Drops

The University of Texas System (UT)

Status: Completed

Conditions: Low Vision Aids

Treatments: Device: Tactile Labels for Drug identity and dose frequency

Study type: Interventional

Funder types: Other

Identifiers

NCT04483882

20-0087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Phase I- Visually Obscured Healthy Subjects

Sham Comparator group

Description:

Tactile label to be evaluated by healthy subjects without visual defect. Subjects in visually obscuring lenses but without peripheral neuropathies or other tactile deficits will evaluate the tactile labeling product for efficacy in drug identity and dosing definition. .

Treatment:

Device: Tactile Labels for Drug identity and dose frequency

Phase II- Low Vision Over 50 years of age

Active Comparator group

Description:

Subjects with documented Low Vision of 20/70 or less or visual field less than 20 degrees will be asked to evaluate tactile labeling product for efficacy in drug identity and dosing definition.

Treatment:

Device: Tactile Labels for Drug identity and dose frequency