Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population (POPH)

November 30, 2016 updated by: Patrick Hamel, Université de Montréal

Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener. The photoscreener results will be compared to the complete ophthalmologic evaluation. Primarily, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Secondarily, this study will gather epidemiological information on vision problems in the haitian children population.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Screening of haitian children between the ages of 3 and 6 years old for amblyogenic risk factors with the use of the Spot photoscreener before and after cycloplegia. The photoscreener results will be compared to the complete ophthalmologic evaluation. The ophthalmologic evaluation includes visual acuity, ocular alignment, slit lamp evaluation, cycloplegic refraction and dilated fundus evaluation. First of all, this will allow evaluation of the performance of the spot photoscreener in the haitian children population. Second of all, this study will gather epidemiological information on vision problems in the haitian children population.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Haiti
      • Limbé, Haiti
        • École Adventiste de Limbé
      • Plaine du Nord, Haiti
        • École Saint-Dominique de Plaine du nord
      • Pétionville, Haiti
        • ClinicA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Haitian children aged 3-6 years of age in Limbé, plaine du Nord and Port-au-Prince

Description

Inclusion Criteria:

  • Haitian children aged 3-6 years of age
  • Signed consent form from a legal guardian

Exclusion Criteria:

  • Previous vision problem diagnostic
  • Unsigned consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spot photoscreener
Automated vision screener: Spot Vision Screener VS 100, Welch-Allyn. This photoscreener is a portable device, using an infrared light. It is built to detect amblyogenic risk factors. First of all, the spot photoscreener produces a sounds which attracts the child's attention and helps him shift his gaze towards the device, held at 1 meter in front him. The spot then evaluates for refractive errors, anisocoria, strabismus, ptosis and media opacity. The ophthalmologic evaluation consists of the measure of the visual acuity, ocular alignment, anterior and posterior segment. The patient will be cyclopleged with cycloplegic drops and will be refracted to obtain a cyclopleged refraction. This will determine his refractive error.
Device: Spot photoscreener
Screening of vision problem through an automated device
Procedure: Ophthalmologic evaluation
Screening of vision problem through an ophthalmologic evaluation
Procedure: Cyclopleged refraction
Screening of refractive problems through a cyclopleged optometric refraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population
Time Frame: 7 days
The epidemiology of vision problems will be evaluated in a sample of haitian children. The ophthalmologic exam will be considered abnormal if it denotes a significant ophthalmologic pathology. A significant ophthalmologic pathology is defined as a significant refractive error, a significant strabismus or a significant media opacity according to the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS) Guidelines for automated preschool vision screening. An ophthalmologic pathology is also considered significant in cases of severe ophthalmologic pathologies (xerophthalmia, trachoma, cataract >1mm, glaucoma, retinopathy of prematurity, retinoblastoma).
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote significant ophthalmologic pathologies according to the 2013 AAPOS guidelines in an haitian pediatric population
Time Frame: 7 days
Sensitivity, specificity, positive predictive value and negative predictive value of the abnormal automated vision screening with the photoscreener in comparison of the abnormal screening of the ophthalmologic exam using the criteria of the AAPOS guidelines (gold standard). A significant ophthalmologic pathology is defined as a significant refractive error, a significant strabismus or a significant media opacity according to the 2013 American Association for Pediatric Ophthalmology and Strabismus (AAPOS). The results of the test, being normal vs abnormal, will be compared.
7 days
Performance of the Spot photoscreeners in comparison with the ophthalmologic exam to denote severe ophthalmologic pathologies that are not described in the 2013 AAPOS guidelines in an haitian pediatric population
Time Frame: 7 days
Sensitivity, specificity, positive predictive value and negative predictive value of the abnormal automated vision screening with the photoscreener in comparison of the abnormal screening of the ophthalmologic exam for all other severe ophthalmologic pathologies not described in the AAPOS guidelines (gold standard). An ophthalmologic pathology is also considered significant in cases of severe ophthalmologic pathologies (xerophthalmia, trachoma, cataract >1mm, glaucoma, retinopathy of prematurity, retinoblastoma). The results of the test, being normal vs abnormal, will be compared.
7 days
Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population
Time Frame: 7 days
Sensitivity, specificity of the refractive errors measured with the photoscreener compared to the refractive errors measured by the cyclopleged optometric exam (gold standard). The values of the refraction, in dioptries, will be compared.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: Antoine Sylvestre-Bouchard, Université de Montréal
  • Study Chair: Patrick Hamel, MD, FRCS, Université de Montréal
  • Study Director: Christelle Doyon, MD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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