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

NCT02655432 | Withdrawn

• 1 other identifier: 20160130
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  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

  7 days

• Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population

  7 days

Study Arms (1)

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; Procedure: Ophthalmologic evaluation; Procedure: Cyclopleged refraction

Interventions

Spot photoscreener DEVICE

Screening of vision problem through an automated device

Spot photoscreener

Ophthalmologic evaluation PROCEDURE

Screening of vision problem through an ophthalmologic evaluation

Spot photoscreener

Cyclopleged refraction PROCEDURE

Screening of refractive problems through a cyclopleged optometric refraction

Spot photoscreener

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Haitian children aged 3-6 years of age in Limbé, plaine du Nord and Port-au-Prince

You may qualify if:

• Haitian children aged 3-6 years of age
• Signed consent form from a legal guardian

You may not qualify if:

• Previous vision problem diagnostic
• Unsigned consent form

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (3)

École Adventiste de Limbé

Lenbe, Haiti

Location

ClinicA

Pétionville, Haiti

Location

École Saint-Dominique de Plaine du nord

Plaine du Nord, Haiti

Location

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MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Refractive Errors; Lens Diseases; 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; Eye Diseases, Hereditary; Retinal Diseases; Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Ocular Hypertension; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Antoine Sylvestre-Bouchard

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Patrick Hamel, MD, FRCS

  Université de Montréal

  STUDY CHAIR

• Christelle Doyon, MD

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital chef of the ophthalmology department, CHU Sainte-Justine

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

HA (3)