Functional Assessments in Vision Impairment

NCT ID: NCT06908161

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-31

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.

Conditions

Retinitis Pigmentosa (RP); Diabetic Retinopathy (DR); Age Related Macular Degeneration (AMD); Glaucoma; Retinal Dystrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

1. Willing to provide signed informed consent.

2. Be available for study visits.

3. Willing to comply with study assessments.

4. In good general health and ambulant.

5. Aged over 18 years of age.

6. Have a vision impairment caused by any ocular condition which affects independent mobility.

7. Agree to allow the research team into their home and local environments.

8. Participate in assessments in public settings

Exclusion Criteria

1. Significant co-morbidities which prohibit involvement in study visits.

2. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

3. Cognitive deficiencies, including dementia or progressive neurological disease.

4. Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder.

5. Deafness or significant hearing loss.

6. Inability to converse in English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Eye Research Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Penelope J Allen, FRACO, FRACS

Role: PRINCIPAL_INVESTIGATOR

Center for Eye Research Australia

Locations

Centre for Eye Research Australia

Melbourne, Victoria, Australia

Countries

Australia

Central Contacts

Lisa Lombardi, BOptom

Role: CONTACT

llombardi@cera.org.au

+61 3 9959 0119

Lauren Moussallem, BAppSc MOrth

Role: CONTACT

lmoussallem@unimelb.edu.au

Other Identifiers

24/1642H

Identifier Type: -

Identifier Source: org_study_id