Evaluation of Tests Performance on a New Digital Orthoptic Platform

Visual Impairment Clinical Trial

— ESPPADON  

Official title:

Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651389
• Other study ID #: RB 15.087 - ESPPADON
• Status: Completed
• Phase: N/A
• First received: December 29, 2015
• Last updated: April 13, 2017
• Start date: February 18, 2016
• Est. completion date: September 29, 2016

Study information

• Verified date: April 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 29, 2016
• Est. primary completion date: September 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Binocular Vision Disorder
• Vision Disorders
• Visual Impairment

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Ocular Convergence as Measured by the Two Machines		through study completion, an average of 1 hour