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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06908161




Registration number
NCT06908161
Ethics application status
Date submitted
20/03/2025
Date registered
3/04/2025
Date last updated
3/04/2025

Titles & IDs
Public title
Functional Assessments in Vision Impairment
Scientific title
A Novel Approach for Capturing Real-world Functional Assessment Outcomes in Participants With a Vision Impairment
Secondary ID [1] 0 0
24/1642H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa (RP) 0 0
Diabetic Retinopathy (DR) 0 0
Age Related Macular Degeneration (AMD) 0 0
Glaucoma 0 0
Retinal Dystrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluating validity and reliability
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From enrolment to assessment could range from 2 to 4 weeks.

Eligibility
Key inclusion criteria
1. Willing to provide signed informed consent.
2. Be available for study visits.
3. Willing to comply with study assessments.
4. In good general health and ambulant.
5. Aged over 18 years of age.
6. Have a vision impairment caused by any ocular condition which affects independent mobility.
7. Agree to allow the research team into their home and local environments.
8. Participate in assessments in public settings
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant co-morbidities which prohibit involvement in study visits.
2. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
3. Cognitive deficiencies, including dementia or progressive neurological disease.
4. Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder.
5. Deafness or significant hearing loss.
6. Inability to converse in English.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Penelope J Allen, FRACO, FRACS
Address 0 0
Center for Eye Research Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Lombardi, BOptom
Address 0 0
Country 0 0
Phone 0 0
+61 3 9959 0119
Email 0 0
llombardi@cera.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06908161