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Recruiting

NCT Number: NCT05028712

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.

Recruiting

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Key information

Conditions

Low Vision Blindness Eye Diseases Functional Visual Loss Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUNY College of Optometry

New York, 10036, United States

Location status: Recruiting

Location contact

Arathy G Kartha, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Visual Information Training

Behavioral

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

Multimodal training

Behavioral

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

Primary outcomes

  1. 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

  1. Change in hand-eye coordination

    Time frame: 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.

  2. Change in hearing ability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arathy Kartha, PhD

CONTACT

[email protected]

4243981727

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2021
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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