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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lombardi, BOptom | Contact | +61 3 9959 0119 | llombardi@cera.org.au | |
| Lauren Moussallem, BAppSc MOrth | Contact | lmoussallem@unimelb.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Penelope J Allen, FRACO, FRACS | Center for Eye Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Eye Research Australia | Melbourne | Victoria | 3002 | Australia |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D003930 | Diabetic Retinopathy |
| D008268 | Macular Degeneration |
| D005901 | Glaucoma |
| D058499 | Retinal Dystrophies |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009798 | Ocular Hypertension |