Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4 (ORTHOPHTALMO)

Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.

The screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.

The aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.

The orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.

Therefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.

Based on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity > 90% and sensitivity > 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol

Study Overview

• Status: Completed
• Conditions: Visual Impairment in Children

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31300
      • Ophtalmologie Rive Gauche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 3 to 4 years old, girls or boys, with a medical reason for consultation (paediatric orientation) or parent's request (child's complaint)

Description

Inclusion Criteria:

• Children from 3 to 4 years old consulting for a screening of visual disorders,
• Patients registered with French social security scheme,
• Not participating in any other clinical study,
• Consent obtained from one of the two parents or the legal representative.

Exclusion Criteria:

• Children whose parent or legal representative is vulnerable according to article L1121-6 of the CSP,
• Children whose parent or legal guardian is under guardianship or trusteeship or under legal protection,
• Children, whose parent or legal guardian is unable to give consent, or is protected by law.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need to refer the child to an ophthalmologist (YES/NO)	the addressing requirements is evaluated by the orthoptist and ophthalmologist based on the patient's chart and clinical examinations	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of parental satisfaction (algorithmically calculate)	Assessed by the Likert scale (satisfaction questionnaire)	through study completion, an average of 1 year
The number of ophthalmologic consultations saved	Evaluated according to the tariffs of the different nomenclatures of the acts	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Clinique Rive Gauche
• Investigators: Principal Investigator: Dominique Dr Thouvenin, Ophtalmologie Rive Gauche

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2020
• Primary Completion (Actual): June 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: 01/2020; 2020-A00262-37 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No