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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028712
• Other study ID #: IRB00290776
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: State University of New York College of Optometry
• Contact: Arathy Kartha, PhD
• Phone: 4243981727
• Email: akartha[@]sunyopt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• <12 years of age

• dependent on sighted guide

• cognitive impairment

Related Conditions & MeSH terms

• Blindness
• Functional Visual Loss
• Low Vision Blindness
• Quality of Life
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• Visual Information Training
Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.
• Multimodal training
Participants in this arm will receive training in integrating input from different senses to enhance functional performance.

Locations

Country	Name	City	State
United States	SUNY College of Optometry	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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