Studies
| 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 |
Conditions
| 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 |
Interventions
| 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. |
Keywords
| 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 |
Sponsors
| 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 |
| akartha@sunyopt.edu | gislin@lions.med.jhu.edu | ||
| 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 |
Eligibilities
| 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 |
Designs
| 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 |