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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2016
Main ID:	NCT02655432
Date of registration:	08/01/2016
Prospective Registration:	No
Primary sponsor:	Université de Montréal
Public title:	Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population POPH
Scientific title:	Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti
Date of first enrolment:	January 2016
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT02655432
Study type:	Observational
Study design:	Observational Model: Case-Only, Time Perspective: Retrospective
Phase:

Countries of recruitment
Haiti

Contacts

Name:	Antoine Sylvestre-Bouchard
Address:
Telephone:
Email:
Affiliation:	Université de Montréal

Name:	Patrick Hamel, MD, FRCS
Address:
Telephone:
Email:
Affiliation:	Université de Montréal

Name:	Christelle Doyon, MD
Address:
Telephone:
Email:
Affiliation:	Université de Montréal

Key inclusion & exclusion 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

Age minimum: 3 Years
Age maximum: 6 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Retinopathy of Prematurity

Xerophthalmia

Glaucoma

Cataract

Retinoblastoma

Myopia

Trachoma

Amblyopia

Astigmatism

Hyperopia

Intervention(s)

Procedure: Ophthalmologic evaluation

Device: Spot photoscreener

Procedure: Cyclopleged refraction

Primary Outcome(s)

Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population [Time Frame: 7 days]

Secondary Outcome(s)

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]

Performance of the Spot photoscreeners in comparison with the cyclopleged optometric exam in an haitian pediatric population [Time Frame: 7 days]

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]

Secondary ID(s)

20160130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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