Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Amblyopia, Myopia, Hyperopia, Astigmatism, Cataract, Retinoblastoma, Trachoma, Xerophthalmia, Glaucoma, Retinopathy of Prematurity

Intervention / Treatment
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* Device: Spot photoscreener
* Procedure: Ophthalmologic evaluation
* Procedure: Cyclopleged refraction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spot photoscreener<br>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<br>* Screening of vision problem through an automated device<br>Procedure: Ophthalmologic evaluation<br>* Screening of vision problem through an ophthalmologic evaluation<br>Procedure: Cyclopleged refraction<br>* Screening of refractive problems through a cyclopleged optometric refraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population | 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 | 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 | 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 | 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 |