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Clinical Trials/NCT05028712
NCT05028712
Recruiting
Not Applicable

Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

State University of New York College of Optometry1 site in 1 country36 target enrollmentMarch 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Vision Blindness
Sponsor
State University of New York College of Optometry
Enrollment
36
Locations
1
Primary Endpoint
Change in visual ability
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.

Registry
clinicaltrials.gov
Start Date
March 8, 2024
End Date
July 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
State University of New York College of Optometry
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • People with ultra low vision (visual acuity ≤20/1600)

Exclusion Criteria

  • \<12 years of age
  • dependent on sighted guide
  • cognitive impairment

Outcomes

Primary Outcomes

Change in visual ability

Time Frame: Baseline, 1 month, 3 months, 6 months

Change in visual ability as measured by the Ultra Low Vision Visual Function Questionnaire. The scale measures both visual ability (Person Measure) and difficulty (Item Measure) in people with ultra low vision. 150 items on a likert scale ranging from 1 impossible, to 4 not difficult. Using a Rasch-Andrich rating model, Person Measures range from -6 to +2.8 logits, Item Measures range from -3.3 to +3.0 logits. Higher scores indicating better outcome.

Secondary Outcomes

  • Change in hearing ability(Baseline, 1 month, 3 months, 6 months)
  • Change in hand-eye coordination(Baseline, 1 month, 3 months, 6 months)

Study Sites (1)

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