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CompletedNCT02651389ESPPADONUpdated Apr 14, 2017

Evaluation of Tests Performance on a New Digital Orthoptic Platform

An observational study in Binocular Vision Disorder and Visual Impairment, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
96
Ages
7 Years and older
Sex
All
01

Study summary

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

Read the detailed description

The demography of ophthalmologists is becoming weaker, many tasks are now performed by orthoptists. To optimize the achievement of orthoptic exams and thus make reliable screening in a shorter time, digital tools are developed. They attempt to renew the orthoptic screening equipment that is still made up of numerous tests, often with old designs that must be handled and adapted to each patient which constitutes a significant loss of time.

It therefore appeared necessary for us to develop a platform of digital tools that integrates major tests used for diagnostic purposes, especially a visual acuity test, a stereoscopic vision test, a fusion test and a digital synoptophore enabling a detailed analysis of disorders of binocular vision.

The purpose of the study is to evaluate this new tool, avoiding the mobilization of patients , and quantify whether this platform is precise, reliable, fast, comfortable and allow the realization of a safe examination for the patient and for orthoptics.

02

Conditions studied

  • Binocular Vision Disorder
  • Visual Impairment

Keywords

  • Digital Orthoptic Platform
  • Vision test
03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's enrollment of 96 is below the median of 125 across 84 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
96 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Correlation of Ocular Convergence as Measured by the Two Machines

    Time frame: through study completion, an average of 1 hour

07

Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02651389
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jan 11, 2016
Start date
Feb 18, 2016
Primary completion
Sep 29, 2016
Completion
Sep 29, 2016
Last update
Apr 14, 2017

Study contacts

Béatrice Cochener, Pr
principal investigator · University Hospital of Brest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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