NCT03234504

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

July 26, 2017

Last Update Submit

June 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Test-retest variability of stereopsis using head mount display

    one visit

Study Arms (1)

Normal healthy volunteers

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

normal healthy volunteers

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.
  • Subjects with a history of ocular surgery within 3 months of the study were excluded.
  • Foreigners or subjects who are unable to understand informed consent were excluded.
  • Subjects with a history of eye problems, including infection, inflammation, cataract, vitreous opacity or retinal diseases were excluded.
  • Subjects with corrected visual acuity of 20/32 in bad eye were excluded.
  • Subjects with significant refractive error considered to be ≥2.00 diopters of anisometropia were excluded.
  • A female who is pregnant, may be pregnant, or is lactating was excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Vision Research, Department of Ophthalmology

Seoul, 03722, South Korea

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

July 24, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations