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

Normal Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03234504
• Other study ID #: 4-2017-0507
• Status: Recruiting
• Start date: July 24, 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: Jinu Han, MD
• Phone: +82-10-3764-7746
• Email: jinuhan[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Normal Healthy Volunteers

Locations

Country	Name	City	State
Korea, Republic of	Institute of Vision Research, Department of Ophthalmology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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