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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Visual Impairment; Functional Visual Loss; Low Vision Blindness
• Intervention / Treatment: Behavioral: Visual Information Training; Behavioral: Multimodal training

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arathy Kartha, PhD; Phone Number: 4243981727; Email: akartha@sunyopt.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • Recruiting
      • SUNY College of Optometry
      • Contact: Arathy G Kartha, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual Information Training	Behavioral: Visual Information Training; Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.
Experimental: Multimodal Training	Behavioral: Multimodal training; Participants in this arm will receive training in integrating input from different senses to enhance functional performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hand-eye coordination	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.	Baseline, 1 month, 3 months, 6 months
Change in hearing ability	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.	Baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: State University of New York College of Optometry
• Collaborators: State University of New York College of Optometry
• Investigators: Principal Investigator: Arathy Kartha, PhD, State University of New York College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ultra low vision rehabilitation; multi sensory; functional vision assessment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vision Disorders
• Other Study ID Numbers: 2087742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No