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RecruitingNCT05028712Updated Dec 11, 2025

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

An interventional study of Visual Information Training and Multimodal training in Low Vision Blindness, Visual Impairment and Quality of Life, sponsored by State University of New York College of Optometry. Recruiting at 1 site in United States. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by State University of New York College of Optometry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
12 Years to 99 Years
Sex
All
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Study 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.

02

Conditions studied

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

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Keywords

  • ultra low vision rehabilitation
  • multi sensory
  • functional vision assessment
03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's planned enrollment of 36 is below the median of 78 across 244 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

State University of New York College of Optometry is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<12 years of age
  • dependent on sighted guide
  • cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Visual Information Training

    Behavioral: Visual Information Training

  • Experimental
    Multimodal Training

    Behavioral: Multimodal training

Interventions

  • BehavioralVisual Information Training

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

  • BehavioralMultimodal training

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

06

What researchers measure

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.

    Time frame: Baseline, 1 month, 3 months, 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1 month, 3 months, 6 months

  2. 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.

    Time frame: Baseline, 1 month, 3 months, 6 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05028712
Lead sponsor
State University of New York College of Optometry
Responsible party
Sponsor
First posted
Aug 31, 2021
Start date
Mar 8, 2024
Primary completion
Jan 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Dec 11, 2025

Study contacts

Arathy Kartha, PhD
Contact
akartha@sunyopt.edu
4243981727
Arathy Kartha, PhD
principal investigator · State University of New York College of Optometry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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