Functional Assessments in Vision Impairment

NCT06908161 | Not Yet Recruiting

• 1 other identifier: 24/1642H
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluating validity and reliability

  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.

  From enrolment to assessment could range from 2 to 4 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Centre for Eye Research Australia (CERA) databases will be utilised to identify potential participants. CERA, Cerulea Clinical Trials and the University of Melbourne (UOM) will communicate about the study via social media channels (Facebook, LinkedIn, Twitter), public presentations made by research staff and the via websites. Communication may also be distributed in e-newsletters, (such as CERA's Eye-News, or the UOM's newsletters), or print publication (such as CERA's Visionary or Annual Review), and may also form part of an editorial style article which includes information about inherited retinal diseases, glaucoma, age-related macular degeneration and other eye conditions and their prevalence in Australia and the broader opportunities to take part in clinical research.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Eye Research Australia: lead

Study Sites (1)

Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Diabetic Retinopathy; Macular Degeneration; Glaucoma; Retinal Dystrophies

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Ocular Hypertension

Study Officials

• Penelope J Allen, FRACO, FRACS

  Center for Eye Research Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Lombardi, BOptom

CONTACT

+61 3 9959 0119; llombardi@cera.org.au

Lauren Moussallem, BAppSc MOrth

CONTACT

lmoussallem@unimelb.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

AU (1)