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AmblyopiaPOPHNCT02655432

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

An observational study of Amblyopia and Myopia, run by Université de Montréal at 3 sites in Haiti.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Amblyopia, Myopia, Hyperopia
What is being tested?
Spot photoscreener, Ophthalmologic evaluation and Cyclopleged refraction
How many people
0 participants
Where
3 sitesHaiti
Study dates
Jan 2016to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

  • Previous vision problem diagnostic
  • Unsigned consent form

Trial locations and contacts

3 sites in 1 country.

Haiti3 sites

  • École Adventiste de Limbé

    Lenbe

  • ClinicA

    Pétionville

  • École Saint-Dominique de Plaine du nord

    Plaine du Nord

Other trials in Haiti

About this study

Official title: Évaluation de l'Utilisation d'un Photoscreener Comme méthode de dépistage Des problèmes Ophtalmologiques pédiatriques en Haïti

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.

Read the 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.

Being tested
Spot photoscreener, Ophthalmologic evaluation, Cyclopleged refraction
Medical subject headings
Amblyopia, Myopia, Hyperopia, Astigmatism, Cataract, Retinoblastoma, Trachoma, Xerophthalmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spot photoscreenerDevice

    Screening of vision problem through an automated device

  • Ophthalmologic evaluationProcedure or surgery

    Screening of vision problem through an ophthalmologic evaluation

  • Cyclopleged refractionProcedure or surgery

    Screening of refractive problems through a cyclopleged optometric refraction

Study groups in NCT02655432
Study groupRoleWhat they receive
Spot photoscreenerAutomated 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.
Receives: Device: Spot photoscreener; Procedure: Ophthalmologic evaluation; Procedure: Cyclopleged refraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 7 days

Secondary outcomes (3)

  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

    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.

    Measured: 7 days

  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

    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.

    Measured: 7 days

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

    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.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Why it stopped: waiting for ethic board approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655432
Sponsor's protocol ID
20160130
Acronym
POPH
Status last verified
Nov 2016
First submitted
8 Jan 2016
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Maida 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.

    PubMed 18772673

  • Resnikoff 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.

    PubMed 18235892

  • Braverman 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.

    PubMed 17700230

  • Mathers 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.

    PubMed 20645997

  • Krumholtz I. Results from a pediatric vision screening and its ability to predict academic performance. Optometry. 2000 Jul;71(7):426-30.

    PubMed 15326895

  • Atkinson 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.

    PubMed 12461713

  • Williams 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.

    PubMed 15665167

  • Roch-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.

    PubMed 18268218

  • Lennerstrand G, Jakobsson P, Kvarnstrom G. Screening for ocular dysfunction in children: approaching a common program. Acta Ophthalmol Scand Suppl. 1995;(214):26-38; discussion 39-40. doi: 10.1111/j.1600-0420.1995.tb00585.x.

    PubMed 8574881

  • Weinstock VM, Weinstock DJ, Kraft SP. Screening for childhood strabismus by primary care physicians. Can Fam Physician. 1998 Feb;44:337-43.

    PubMed 9512837

  • Williams C, Harrad RA, Harvey I, Sparrow JM; ALSPAC Study Team. Screening for amblyopia in preschool children: results of a population-based, randomised controlled trial. ALSPAC Study Team. Avon Longitudinal Study of Pregnancy and Childhood. Ophthalmic Epidemiol. 2001 Dec;8(5):279-95. doi: 10.1080/09286586.2001.11644257.

    PubMed 11922382

  • Williams C, Northstone K, Harrad RA, Sparrow JM, Harvey I; ALSPAC Study Team. Amblyopia treatment outcomes after screening before or at age 3 years: follow up from randomised trial. BMJ. 2002 Jun 29;324(7353):1549. doi: 10.1136/bmj.324.7353.1549.

    PubMed 12089090

  • Fathy VC, Elton PJ. Orthoptic screening for three- and four-year-olds. Public Health. 1993 Jan;107(1):19-23. doi: 10.1016/s0033-3506(05)80488-3. No abstract available.

    PubMed 8475239

  • Atkinson J, Braddick O, Robier B, Anker S, Ehrlich D, King J, Watson P, Moore A. Two infant vision screening programmes: prediction and prevention of strabismus and amblyopia from photo- and videorefractive screening. Eye (Lond). 1996;10 ( Pt 2):189-98. doi: 10.1038/eye.1996.46.

    PubMed 8776448

  • Atkinson J, Braddick O, Nardini M, Anker S. Infant hyperopia: detection, distribution, changes and correlates-outcomes from the cambridge infant screening programs. Optom Vis Sci. 2007 Feb;84(2):84-96. doi: 10.1097/OPX.0b013e318031b69a.

    PubMed 17299337

Questions about this trial

What is this clinical trial studying?

An observational study of Amblyopia and Myopia, run by Université de Montréal at 3 sites in Haiti.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients presenting significant ophthalmologic pathologies in an haitian pediatric population (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655432, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016; AzTrials last refreshed its copy on 26 Oct 2026.

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