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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02655432
Acronym
POPH
Enrollment
0
Registered
2016-01-14
Start date
2016-01-31
Completion date
2016-06-30
Last updated
2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICESpot photoscreener

Screening of vision problem through an automated device

Screening of vision problem through an ophthalmologic evaluation

PROCEDURECyclopleged refraction

Screening of refractive problems through a cyclopleged optometric refraction

Sponsors

Université de Montréal
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population7 daysThe 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).

Secondary

MeasureTime frameDescription
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 population7 daysSensitivity, 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.
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 population7 daysSensitivity, 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.
Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population7 daysSensitivity, 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.

Countries

Haiti

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026