Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display

This prospective study investigated the validity and test-retest reliability of stereopsis test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195 arc of seconds(arc secs)) were generated as separate images on a high resolution phone display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon, Korea). Two images were independently projected to each eye as graded circles with random dot background. While the position of the stimulus changed from among 3 possible locations, the subjects were instructed to select the circle with disparity by pressing the corresponding position on a keypad. The results of the new HMD stereotest were compared to those from standard Randot and TNO stereotests.

Study Overview

• Status: Unknown
• Conditions: Normal Healthy Volunteers

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Institute of Vision Research, Department of Ophthalmology
    • Contact: Jinu Han, MD; Phone Number: +82-10-3764-7746; Email: jinuhan@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

normal healthy volunteers

Description

Inclusion Criteria:

1. The subjects who want or need to visual acuity test or to test for a prescription for glasses visited the hospital. 2. The Subjects' ages ranged from 19 to 60 years in the study.

Exclusion Criteria:

1. Ocular alignment was assessed with cover-uncover and alternate prism cover testing at distance and near. Significant exodeviation included exophoria was considered to be ≥6 prism diopters were excluded.
2. Subjects with a history of ocular surgery within 3 months of the study were excluded.
3. Foreigners or subjects who are unable to understand informed consent were excluded.
4. Subjects with a history of eye problems, including infection, inflammation, cataract, vitreous opacity or retinal diseases were excluded.
5. Subjects with corrected visual acuity of 20/32 in bad eye were excluded.
6. Subjects with significant refractive error considered to be ≥2.00 diopters of anisometropia were excluded.
7. A female who is pregnant, may be pregnant, or is lactating was excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Normal healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between stereopsis with head mount display and stereopsis with Randot or TNO test	Stereopsis results was expressed as arc sec. The association between log arc sec in stereopsis with HMD display and Randot or TNO test were evaluated. Using Bland Altman plot, the mean differences between two stereopsis results were compared.	one visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-retest variability of stereopsis using head mount display	The intraclass coefficient was calculated between initial head mount display stereopsis result and retests.	one visit

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 4-2017-0507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No