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ESPPADON: Evaluation of Tests Performance on a New Digital Orthoptic Platform

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT02651389
Collaborator
(none)
96
Enrollment
1
Location
7.4
Actual Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    96 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques
    Actual Study Start Date :
    Feb 18, 2016
    Actual Primary Completion Date :
    Sep 29, 2016
    Actual Study Completion Date :
    Sep 29, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of Ocular Convergence as Measured by the Two Machines [through study completion, an average of 1 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: Béatrice Cochener, Pr, University Hospital of Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT02651389
    Other Study ID Numbers:
    • RB 15.087 - ESPPADON
    First Posted:
    Jan 11, 2016
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Hospital, Brest
    Digital Orthoptic Platform
    Vision test
    Additional relevant MeSH terms:
    Vision Disorders
    Vision, Low

    Study Results

    No Results Posted as of Apr 14, 2017