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

Not Applicable

Recruiting

• Conditions: Functional Visual Loss; Low Vision Blindness; Visual Impairment; Quality of Life
• Interventions: Behavioral: Visual Information Training; Behavioral: Multimodal training

• Registration Number: NCT05028712
• Lead Sponsor: State University of New York College of Optometry

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Study Start: 2024-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-03
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visual Information Training	Visual Information Training	-
Multimodal Training	Multimodal training	-

Primary Outcome Measures

Name	Time	Method
Change in visual ability	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 Outcome Measures

Name	Time	Method
Change in hearing ability	Baseline, 1 month, 3 months, 6 months	Change in hearing ability as assessed by iHEARtest device (earphones, computer application). The participant presses the space bar on their computer keyboard every time they hear a sound. The iHEARtest provides a Hearing Number™ in each ear on a scale from 1=profound impairment, to 5= no impairment.
Change in hand-eye coordination	Baseline, 1 month, 3 months, 6 months	Change in hand eye coordination as assessed by a leap motion (Ultra Leap) sensor taped to a Virtual Reality headset to track hand eye coordination.

Trial Locations

Locations (1)

SUNY College of Optometry; 🇺🇸 New York, New York, United States