A Novel Approach for Capturing Real-world Functional Assessment Outcomes in Participants With a Vision Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Evaluating validity and reliability
Study Overview
Brief Summary
The aim of the research project is to validate the use of a novel functional assessment tool designed to document how participants with a vision impairment complete activities of daily living in a real world environment.
Detailed Description
There is currently no multisensory tool to assess functional vision in people with a vision impairment. This study is designed to capture and assess the reliability and validity of a novel tool developed by multi-disciplinary experts in ophthalmology, optometry, orthoptics, orientation and mobility (O&M) specialists, and people with lived experience of low vision. The tool is designed to be used in both clinical and in interventional clinical trial setting, to provide functional vision assessment measures within real-world outcomes. The development of this tool is at a critical junction in time where a range, of interventions are being developed for people with low vision including bionic eyes, and gene and cell therapies. The FDA requires trials to show real world functional outcomes in addition to traditional endpoints, hence a tool like the ATOMM may have wide use and implications. This study will recruit participants with varying levels of vision impairment to assess the reliability of the ATOMM.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing to provide signed informed consent.
- •Be available for study visits.
- •Willing to comply with study assessments.
- •In good general health and ambulant.
- •Aged over 18 years of age.
- •Have a vision impairment caused by any ocular condition which affects independent mobility.
- •Agree to allow the research team into their home and local environments.
- •Participate in assessments in public settings
Exclusion Criteria
- •Significant co-morbidities which prohibit involvement in study visits.
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- •Cognitive deficiencies, including dementia or progressive neurological disease.
- •Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder.
- •Deafness or significant hearing loss.
- •Inability to converse in English.
Outcomes
Primary Outcomes
Evaluating validity and reliability
Time Frame: From enrolment to assessment could range from 2 to 4 weeks.
Two investigators will attend the local environments of each participant for repeated sessions at least two weeks apart to conduct functional assessments using the ATOMM. The tool contains 3 domains involving 15 pre-determined tasks, each designed to encompass common activities of daily living. An example includes independently navigating around the home. A maximum score of 30 points/domain is achievable on a 7 point Likert scale. The investigators will use intraclass correlation coefficients (ICC) to quantify the interrater agreement between two assessors and test-retest reliability over the three domains across the two sessions.
Secondary Outcomes
No secondary outcomes reported