Functional Assessments in Vision Impairment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCenter for Eye Research Australia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to provide signed informed consent.

Be available for study visits.

Willing to comply with study assessments.

In good general health and ambulant.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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