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

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ClinicalTrials.gov Identifier: NCT02655432
Recruitment Status : Withdrawn (waiting for ethic board approval)
First Posted : January 14, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
Patrick Hamel, Université de Montréal

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.

Condition or disease Intervention/treatment
Amblyopia Myopia Hyperopia Astigmatism Cataract Retinoblastoma Trachoma Xerophthalmia Glaucoma Retinopathy of Prematurity Device: Spot photoscreener Procedure: Ophthalmologic evaluation Procedure: Cyclopleged refraction

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
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Haitian children aged 3-6 years of age in Limbé, plaine du Nord and Port-au-Prince
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655432


Locations
Haiti
École Adventiste de Limbé
Limbé, Haiti
École Saint-Dominique de Plaine du nord
Plaine du Nord, Haiti
ClinicA
Pétionville, Haiti
Sponsors and Collaborators
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:

Responsible Party: Patrick Hamel, Hospital chef of the ophthalmology department, CHU Sainte-Justine, Université de Montréal
ClinicalTrials.gov Identifier: NCT02655432     History of Changes
Other Study ID Numbers: 20160130
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Trachoma
Cataract
Astigmatism
Retinoblastoma
Amblyopia
Retinopathy of Prematurity
Hyperopia
Xerophthalmia
Lens Diseases
Eye Diseases
Refractive Errors
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Retinal Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Infant, Premature, Diseases