Clinical trial NCT02655432: Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population
Official title: Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amblyopia
Myopia
Hyperopia
Astigmatism
Cataract
Retinoblastoma
Trachoma
Xerophthalmia
Glaucoma
Retinopathy of Prematurity
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Haitian children aged 3-6 years of age in Limbé, plaine du Nord and Port-au-Prince

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population
timeFrame: 7 days
Secondary outcomes:
measure: 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
timeFrame: 7 days
measure: 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
timeFrame: 7 days
measure: Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population
timeFrame: 7 days
Other outcomes:
Locations:
city: Limbé
country: Haiti
facility: École Adventiste de Limbé
city: Plaine du Nord
country: Haiti
facility: École Saint-Dominique de Plaine du nord
city: Pétionville
country: Haiti
facility: ClinicA
Study officials:
affiliation: Université de Montréal
name: Antoine Sylvestre-Bouchard
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Patrick Hamel, MD, FRCS
role: STUDY_CHAIR
affiliation: Université de Montréal
name: Christelle Doyon, MD
role: STUDY_DIRECTOR
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