NCT03242421

Brief Summary

Binocular vision tests are guided by the principle that uniform motion and focus of the eyes may be trained, but exercising the simultaneous movement of the pupils is necessary and important in achieving optimal and lasting results (Horwood \& Toor, 2014). These tests have been in use for over 70 years and represent the foundation of therapy for visual deficiencies such as the inability of the eyes to move together. Despite their frequent use, no one has ever formally evaluated how good these tests are. One such evaluation method is reliability. A reliable test is one that will give the same result when repeated on multiple occasions (i.e. test-retest reliability) or by different people (inter-rater reliability). An unreliable test gives widely varying results when repeated, which would make changes in a patient's test results difficult to interpret. Therefore, this study aims to determine the test-retest reliability of seven binocular vision tests across two independent measurements. The investigators will measure 20 healthy people ages 18 to 35 years for each of these tests on two separate occasions, one week apart. Since these tests have been in use for many years, we are expecting the two measurements to be within acceptable range of each other. The tests being investigated measure: 3D vision (i.e. gross stereoscopic acuity), uniform movement of the eyes (i.e. "motor punctum proximum"), ability of the eyes to adapt to a target moving towards and/or away from the eyes (i.e. binocular fusion with convergence and divergence), quick movements of the eyes (i.e. saccadic movements), natural alignment of the eyes (i.e. anatomic oculomotor deviation), and double vision as a target is moved towards the eyes (i.e. convergence fusional proximum). The results of each test will be analyzed individually. If the tests are perfectly reliable, we would expect the results of the first test to equal the results of the second test for each participant. To examine the test-retest reliability the difference between the first and second test for each individual and across all individuals' scores summed together will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
Last Updated

February 20, 2020

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

August 2, 2017

Last Update Submit

February 19, 2020

Conditions

Keywords

test-retest reliabilityBinocular vision tests

Outcome Measures

Primary Outcomes (1)

  • Change in the results of binocular vision tests (a.k.a. test-retest reliability)

    Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC) which measures the between-group variance divided by the total variance (sum of between- and within-group variance).

    Participants will be evaluated using the binocular vision tests at two time points - one week apart.

Secondary Outcomes (1)

  • Effect modifiers of the test-retest reliability of the binocular vision tests

    1 day first visit

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The target population is healthy adults aged 18 to 35 years. This study is being conducted as part of a larger project examining the correlation of the binocular vision tests with symptoms of concussions; therefore, this population has been selected to match that target population of young adults with concussion symptoms to ensure applicability of findings to the patient population in the larger study. Participants who have conditions or are taking treatments that could affect the results of the binocular vision tests will be excluded.

You may qualify if:

  • Must be 18 to 35 years of age
  • Provide informed consent to participate in study

You may not qualify if:

  • Has strabismus or a history of treated strabismus
  • History of migraine or known neurological disorders
  • Use myorelaxants or medications for depression, anxiety, or other psychological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3G1Y6, Canada

Location

Related Publications (5)

  • Horwood A, Toor S. Clinical test responses to different orthoptic exercise regimes in typical young adults. Ophthalmic Physiol Opt. 2014 Mar;34(2):250-62. doi: 10.1111/opo.12109. Epub 2014 Jan 29.

    PMID: 24471739BACKGROUND
  • Hachana Y, Chaabene H, Nabli MA, Attia A, Moualhi J, Farhat N, Elloumi M. Test-retest reliability, criterion-related validity, and minimal detectable change of the Illinois agility test in male team sport athletes. J Strength Cond Res. 2013 Oct;27(10):2752-9. doi: 10.1519/JSC.0b013e3182890ac3.

    PMID: 23439329BACKGROUND
  • Broglio SP, Ferrara MS, Macciocchi SN, Baumgartner TA, Elliott R. Test-retest reliability of computerized concussion assessment programs. J Athl Train. 2007 Oct-Dec;42(4):509-14.

    PMID: 18174939BACKGROUND
  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

    PMID: 2868172BACKGROUND
  • Rousson V, Gasser T, Seifert B. Assessing intrarater, interrater and test-retest reliability of continuous measurements. Stat Med. 2002 Nov 30;21(22):3431-46. doi: 10.1002/sim.1253.

    PMID: 12407682BACKGROUND

Study Officials

  • Ian Shrier, MD, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator, Centre for Clinical Epidemiology, Lady Davis Institute; Associate Professor, Department of Family Medicine, McGill University

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 8, 2017

Study Start

August 7, 2017

Primary Completion

September 20, 2017

Study Completion

September 20, 2017

Last Updated

February 20, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations