NCT02651389

Brief Summary

This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

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

December 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2016

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

December 29, 2015

Last Update Submit

April 13, 2017

Conditions

Binocular Vision DisorderVisual Impairment

Keywords

Digital Orthoptic PlatformVision test

Outcome Measures

Primary Outcomes (1)

  • Correlation of Ocular Convergence as Measured by the Two Machines

    through study completion, an average of 1 hour

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People performing an orthoptic exam at ophthalmology department of Brest University Hospital.

You may qualify if:

  • Patients with less than or equal to 16 ocular deviation prism diopters, without or with slight amblyopia (maximum difference of 2 logarithmic visual acuity lines) and performing an orthoptic exam at ophthalmology department of Brest University Hospital.

You may not qualify if:

  • monophthalmic
  • Medium and deep amblyopic patients
  • Patients with not normal ocular motility
  • Patient who underwent surgery at the head and neck during the previous three months
  • Children under 7 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Béatrice Cochener, Pr

    University Hospital of Brest

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 11, 2016

Study Start

February 18, 2016

Primary Completion

September 29, 2016

Study Completion

September 29, 2016

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)