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.
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
- What is being tested?
- Spot photoscreener, Ophthalmologic evaluation and Cyclopleged refraction
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 3 sitesHaiti
- Study dates
- Jan 2016to Jun 2016
- Phase
- Observational
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
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.
- Conditions
- Amblyopia, Myopia, Hyperopia, Astigmatism, Cataract, Retinoblastoma
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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
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
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.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: waiting for ethic board approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Hamel, Université de Montréal
- Investigators
- Antoine Sylvestre-Bouchard, Principal investigator, Université de MontréalPatrick Hamel, MD, FRCS, Study chair, Université de MontréalChristelle Doyon, MD, Study director, Université de Montréal
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 18772673Resnikoff 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 18235892Braverman 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 17700230Mathers 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 20645997Krumholtz I. Results from a pediatric vision screening and its ability to predict academic performance. Optometry. 2000 Jul;71(7):426-30.
PubMed 15326895Atkinson 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 12461713Williams 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 15665167Roch-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 18268218Lennerstrand 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 8574881Weinstock VM, Weinstock DJ, Kraft SP. Screening for childhood strabismus by primary care physicians. Can Fam Physician. 1998 Feb;44:337-43.
PubMed 9512837Williams 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 11922382Williams 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 12089090Fathy 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 8475239Atkinson 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 8776448Atkinson 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