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


Study First Submitted Date 2021-08-25
Study First Posted Date 2021-08-31
Last Update Posted Date 2023-08-09
Start Month Year March 2024
Primary Completion Month Year December 2024
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-09


Sequence: 52305892 Sequence: 52305893 Sequence: 52305894 Sequence: 52305895
Name Low Vision Blindness Name Visual Impairment Name Quality of Life Name Functional Visual Loss
Downcase Name low vision blindness Downcase Name visual impairment Downcase Name quality of life Downcase Name functional visual loss

Id Information

Sequence: 40255457
Id Source org_study_id
Id Value IRB00290776

Design Groups

Sequence: 55743686 Sequence: 55743687
Group Type Experimental Group Type Experimental
Title Visual Information Training Title Multimodal Training


Sequence: 52617755 Sequence: 52617756
Intervention Type Behavioral Intervention Type Behavioral
Name Visual Information Training Name Multimodal training
Description Participants in this arm will receive training to improve the use of residual vision to enhance functional performance. Description Participants in this arm will receive training in integrating input from different senses to enhance functional performance.


Sequence: 80056711 Sequence: 80056712 Sequence: 80056713
Name ultra low vision rehabilitation Name multi sensory Name functional vision assessment
Downcase Name ultra low vision rehabilitation Downcase Name multi sensory Downcase Name functional vision assessment

Design Outcomes

Sequence: 177875618 Sequence: 177875619 Sequence: 177875620
Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Change in visual ability Measure Change in hand-eye coordination Measure Change in hearing ability
Time Frame Baseline, 1 month, 3 months, 6 months Time Frame Baseline, 1 month, 3 months, 6 months Time Frame Baseline, 1 month, 3 months, 6 months
Description 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. Description 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. Description 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.

Browse Conditions

Sequence: 194001303 Sequence: 194001304 Sequence: 194001305 Sequence: 194001306 Sequence: 194001307 Sequence: 194001308 Sequence: 194001309
Mesh Term Vision Disorders Mesh Term Vision, Low Mesh Term Blindness Mesh Term Sensation Disorders Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases Mesh Term Eye Diseases
Downcase Mesh Term vision disorders Downcase Mesh Term vision, low Downcase Mesh Term blindness Downcase Mesh Term sensation disorders Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases Downcase Mesh Term eye diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48445692 Sequence: 48445693
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Johns Hopkins University Name State University of New York College of Optometry

Overall Officials

Sequence: 29357714
Role Principal Investigator
Name Arathy Kartha, PhD
Affiliation State University of New York College of Optometry

Central Contacts

Sequence: 12041777 Sequence: 12041778
Contact Type primary Contact Type backup
Name Arathy Kartha, PhD Name Gislin Dagnelie, PhD
Phone 4243981727 Phone 4103021792
Email Email
Role Contact Role Contact

Design Group Interventions

Sequence: 68331274 Sequence: 68331275
Design Group Id 55743686 Design Group Id 55743687
Intervention Id 52617755 Intervention Id 52617756


Sequence: 30843642
Gender All
Minimum Age 12 Years
Maximum Age 99 Years
Healthy Volunteers No
Criteria Inclusion Criteria: People with ultra low vision (visual acuity ≤20/1600) Exclusion Criteria: <12 years of age dependent on sighted guide cognitive impairment
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254190424
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 12
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 2


Sequence: 30589514
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 28955961
Responsible Party Type Sponsor