- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530773
Developing and Validating VR-Enabled Ophthalmic Clinics: A New Paradigm for Visual Function Testing
June 6, 2025 updated by: Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
This study aimed to design and validate a VR-based ophthalmic clinic that replicates traditional tests of visual acuity, stereopsis, and contrast sensitivity within an immersive digital environment.
Using a rigorously developed system based onprogrammable interfaces, and standardized testing paradigms, we compared VR assessments against gold-standard clinical tools in a cohort of healthy adult participants.
Key outcomes included test consistency, correlation, user acceptability, visual fatigue, and time efficiency.
Our findings offer evidence for the viability of VR as a platform for remote ophthalmic testing and pave the way for scalable digital eye care delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Zhongshan Opthalmic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The study included healthy individuals older than 18 years of age with a best-corrected visual acuity (BCVA) of <0.1 logarithm of minimum angle of resolution (logMAR) and no ongoing or prior history of ocular or systemic disease.
Exclusion Criteria:
- The study excluded healthy individuals younger than 18 years of age with a best-corrected visual acuity (BCVA) of >0.1 logarithm of minimum angle of resolution (logMAR) with ongoing or prior history of ocular or systemic disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GROUP1
|
The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
|
|
Experimental: GROUP2
|
The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
|
|
Experimental: GROUP3
|
The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
|
|
Experimental: GROUP4
|
The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
|
|
Experimental: GROUP5
|
The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accommodative Response
Time Frame: 60 min
|
The actual amount of accommodation that exists is measured with a skiascope
|
60 min
|
|
AC/A Ratio
Time Frame: 60 min
|
The ratio of accommodation convergence to accommodation is measured and calculated by maddox
|
60 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 6, 2025
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2020KYPJ092
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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