An observational study in Retinitis Pigmentosa (RP), Diabetic Retinopathy (DR) and Age Related Macular Degeneration (AMD), sponsored by Center for Eye Research Australia. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Center for Eye Research Australia · Observational
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.
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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 45 is below the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Center for Eye Research Australia is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Center for Eye Research Australia