Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001153505
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a virtual three-dimensional eye model on patient satisfaction and understanding: a randomised control trial
Scientific title
The effect of a virtual three-dimensional eye model on patient satisfaction and understanding: a randomised control trial
Secondary ID [1] 312809 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ORE (One Right Eye)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 335115 0
Age-related macular degeneration 335116 0
Diabetic retinopathy 335117 0
Retinal vein occlusion 335118 0
Condition category
Condition code
Eye 331430 331430 0 0
Diseases / disorders of the eye
Public Health 331802 331802 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention = a standard ophthalmic consultation assisted by an interactive virtual three-dimensional eye model (One Right Eye) on the doctor’s computer. The One Right Eye (ORE) is a virtual, interactive, three-dimensional model of the right human eye that can be loaded on any smart device with internet access (onerighteye.com). The model uses innovative digital tools to create a detailed, immersive simulation of common eye conditions and how they progress. The use of the virtual eye model during the consult is at the doctor's discretion.
Intervention code [1] 329347 0
Treatment: Other
Comparator / control treatment
Control = a standard public outpatient ophthalmic consultation equal to that of non-participating patients.
Control group
Active

Outcomes
Primary outcome [1] 339185 0
Overall patient satisfaction
Timepoint [1] 339185 0
At the end of the appointment (one-time point). The patients will not be followed up.
Secondary outcome [1] 438976 0
Patients’ rating of their doctors' explanation.
Timepoint [1] 438976 0
At the end of the appointment (one-time point). The patients will not be longitudinally followed up.
Secondary outcome [2] 439614 0
Patients' post-clinic understanding of their ophthalmic condition.
Timepoint [2] 439614 0
At the end of the appointment (one-time point). The patients will not be longitudinally followed up.
Secondary outcome [3] 439615 0
The likelihood of patients needing to review their doctors' explanation at home.
Timepoint [3] 439615 0
At the end of the appointment (one-time point). The patients will not be longitudinally followed up.

Eligibility
Key inclusion criteria
All adult patients presenting to a public ophthalmology clinic (except for injection clinics).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Declining to participate
- Legally blind
- Cognitively impaired
- Primary language other than English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur via the opaque envelope approach whereby sealed opaque envelopes are thoroughly shuffled and placed in a stack at the nurses’ station at the ophthalmology clinic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: taking the opaque envelope at the top of a shuffled stack.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Reached statistical significance
Date of first participant enrolment
Anticipated
Actual
22/05/2023
Date of last participant enrolment
Anticipated
Actual
14/11/2023
Date of last data collection
Anticipated
Actual
14/11/2023
Sample size
Target
244
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317245 0
Hospital
Name [1] 317245 0
Ophthalmology Department, The Royal Melbourne Hospital
Country [1] 317245 0
Australia
Primary sponsor type
Hospital
Name
Ophthalmology Department, The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 319524 0
None
Name [1] 319524 0
Address [1] 319524 0
Country [1] 319524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315981 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315981 0
Ethics committee country [1] 315981 0
Australia
Date submitted for ethics approval [1] 315981 0
21/04/2021
Approval date [1] 315981 0
01/12/2021
Ethics approval number [1] 315981 0
HREC/75734/MH-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136418 0
A/Prof Elaine Chong
Address 136418 0
The Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 136418 0
Australia
Phone 136418 0
+61 3 93428133
Fax 136418 0
Email 136418 0
[email protected]
Contact person for public queries
Name 136419 0
Emma Tovey Crutchfield
Address 136419 0
The Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 136419 0
Australia
Phone 136419 0
+61 432598581
Fax 136419 0
Email 136419 0
[email protected]
Contact person for scientific queries
Name 136420 0
Emma Tovey Crutchfield
Address 136420 0
The Royal Melbourne Hospital, 300 Grattan St, Parkville, VIC, 3052
Country 136420 0
Australia
Phone 136420 0
+61 432598581
Fax 136420 0
Email 136420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.