Clinical trial · Observational
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
NCT02655432CI-TRIAL-00024981POPHwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): waiting for ethic board approval
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amblyopia | — | UNRESOLVED | — |
| Astigmatism | — | UNRESOLVED | — |
| Cataract | — | UNRESOLVED | — |
| Glaucoma | — | UNRESOLVED | — |
| Hyperopia | — | UNRESOLVED | — |
| Myopia | — | UNRESOLVED | — |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
| Retinopathy of Prematurity | — | UNRESOLVED | — |
| Trachoma | — | UNRESOLVED | — |
| Xerophthalmia | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclopleged refraction | Procedure | — | UNRESOLVED |
| Ophthalmologic evaluation | Procedure | — | UNRESOLVED |
| Spot photoscreener | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spot photoscreener
- description
- 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.
- interventionNames
- Device: Spot photoscreener
- Procedure: Ophthalmologic evaluation
- Procedure: Cyclopleged refraction
Primary outcomes (1)
- measure
- Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population
- timeFrame
- 7 days
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 6 Years
Show eligibility criteria text
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
References
Publications (36)
- BACKGROUNDMaida JM, Mathers K, Alley CL. Pediatric ophthalmology in the developing world. Curr Opin Ophthalmol. 2008 Sep;19(5):403-8. doi: 10.1097/ICU.0b013e328309f180. PMID 18772673
- BACKGROUNDResnikoff S, Pascolini D, Mariotti SP, Pokharel GP. Global magnitude of visual impairment caused by uncorrected refractive errors in 2004. Bull World Health Organ. 2008 Jan;86(1):63-70. doi: 10.2471/blt.07.041210. PMID 18235892
- BACKGROUNDBraverman R. Diagnosis and treatment of refractive errors in the pediatric population. Curr Opin Ophthalmol. 2007 Sep;18(5):379-83. doi: 10.1097/ICU.0b013e328244dfed. PMID 17700230
- BACKGROUNDMathers M, Keyes M, Wright M. A review of the evidence on the effectiveness of children's vision screening. Child Care Health Dev. 2010 Nov;36(6):756-80. doi: 10.1111/j.1365-2214.2010.01109.x. PMID 20645997
- BACKGROUNDKrumholtz I. Results from a pediatric vision screening and its ability to predict academic performance. Optometry. 2000 Jul;71(7):426-30. PMID 15326895
- BACKGROUNDAtkinson J, Anker S, Nardini M, Braddick O, Hughes C, Rae S, Wattam-Bell J, Atkinson S. Infant vision screening predicts failures on motor and cognitive tests up to school age. Strabismus. 2002 Sep;10(3):187-98. doi: 10.1076/stra.10.3.187.8125. PMID 12461713
- BACKGROUNDWilliams WR, Latif AH, Hannington L, Watkins DR. Hyperopia and educational attainment in a primary school cohort. Arch Dis Child. 2005 Feb;90(2):150-3. doi: 10.1136/adc.2003.046755. PMID 15665167
- BACKGROUNDRoch-Levecq AC, Brody BL, Thomas RG, Brown SI. Ametropia, preschoolers' cognitive abilities, and effects of spectacle correction. Arch Ophthalmol. 2008 Feb;126(2):252-8; quiz 161. doi: 10.1001/archophthalmol.2007.36.