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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I- Visually Obscured Healthy Subjects | Sham Comparator | 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. . |
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| Phase II- Low Vision Over 50 years of age | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tactile Labels for Drug identity and dose frequency | Device | The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed. |
| Measure | Description | Time Frame |
|---|---|---|
| Correct Drug Identity by Shape | Subjects Assessment and Report of drug identity by shape of label protrusions | 2 minutes |
| Correct Drug Identity by Color | Subject Assessment and Report of drug identity by color of tactile label | 2 minutes |
| 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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IInclusion Criteria:
Phase I:
Exclusion Criteria:
Phase I:
Phase II;
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| Name | Affiliation | Role |
|---|---|---|
| Praveena Gupta, O.D., Ph.D. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch, Ophthalmology Clinical Research Center | Galveston | Texas | 77555 | United States |
Individual's data will not be shared in an identifiable format.
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Single Group, Blinded, Sham controlled study
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Subjects will be blinded to product to be provided for visual and tactile definition of label product and type and frequency of prescription.
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |