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

NCT05028712 | Recruiting

• 1 other identifier: 2087742
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision Blindness; Quality of Life; Functional Visual Loss; Visual Impairment

Keywords

ultra low vision rehabilitation; multi sensory; functional vision assessment

Outcome Measures

Primary Outcomes (1)

• Change in visual ability

  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.

  Baseline, 1 month, 3 months, 6 months

Secondary Outcomes (2)

• Change in hand-eye coordination

  Baseline, 1 month, 3 months, 6 months

• Change in hearing ability

  Baseline, 1 month, 3 months, 6 months

Study Arms (2)

Visual Information Training

EXPERIMENTAL

Behavioral: Visual Information Training

Multimodal Training

EXPERIMENTAL

Behavioral: Multimodal training

Interventions

Visual Information Training BEHAVIORAL

Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.

Visual Information Training

Multimodal training BEHAVIORAL

Participants in this arm will receive training in integrating input from different senses to enhance functional performance.

Multimodal Training

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York College of Optometry: lead

Study Sites (1)

SUNY College of Optometry

New York, New York, 10036, United States

RECRUITING

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arathy Kartha, PhD

  State University of New York College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arathy Kartha, PhD

CONTACT

4243981727; akartha@sunyopt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: March 8, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)