Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-99
SponsorState University of New York College of Optometry
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People with ultra low vision (visual acuity ≤20/1600)
Disqualifiers
<12 years of age
dependent on sighted guide
cognitive impairment
Trial design
Design model
Crossover
Treatments tested in this trial
Visual Information Training
BehavioralParticipants in this arm will receive training to improve the use of residual vision to enhance functional performance.
Multimodal training
BehavioralParticipants in this arm will receive training in integrating input from different senses to enhance functional performance.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Visual Information TrainingExperimental treatment 1 intervention
Group B: Multimodal TrainingExperimental treatment 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov