Evaluation of Tests Performance on a New Digital Orthoptic Platform

Completed

• Conditions: Visual Impairment; Binocular Vision Disorder

• Registration Number: NCT02651389
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-02-18
• Primary Completion: 2016-09-29
• Study Completion: 2016-09-29
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of Ocular Convergence as Measured by the Two Machines	through study completion, an average of 1 hour

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France