NCT06908161

Functional Assessments in Vision Impairment

A Novel Approach for Capturing Real-world Functional Assessment Outcomes in Participants With a Vision Impairment

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Center for Eye Research Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-04-03
• Last updated: 2025-04-03

Locations

1 site across 1 country: Australia