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

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Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population

Secondary Outcome

 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

Condition

Amblyopia

Intervention

Spot photoscreener

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

January 2016

Completion Date

June 2016

Primary Completion Date

June 2016

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
      

Gender

All

Ages

3 Years - 6 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Antoine Sylvestre-Bouchard, , 

Location Countries

Haiti

Location Countries

Haiti

Administrative Informations


NCT ID

NCT02655432

Organization ID

20160130


Responsible Party

Principal Investigator

Study Sponsor

Université de Montréal


Study Sponsor

Antoine Sylvestre-Bouchard, Principal Investigator, Université de Montréal


Verification Date

November 2016