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

Cataract Clinical Trial

— POPH  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02655432
• Other study ID #: 20160130
• Status: Withdrawn
• Phase: Phase 0
• First received: January 8, 2016
• Last updated: November 30, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Device:
• Spot photoscreener
Screening of vision problem through an automated device

Procedure:
• Ophthalmologic evaluation
Screening of vision problem through an ophthalmologic evaluation
• Cyclopleged refraction
Screening of refractive problems through a cyclopleged optometric refraction

Locations

Country	Name	City	State
Haiti	École Adventiste de Limbé	Limbé
Haiti	ClinicA	Pétionville
Haiti	École Saint-Dominique de Plaine du nord	Plaine du Nord

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Haiti, 

References & Publications (36)

Arnold RW, Armitage MD. Performance of four new photoscreeners on pediatric patients with high risk amblyopia. J Pediatr Ophthalmol Strabismus. 2014 Jan-Feb;51(1):46-52. doi: 10.3928/01913913-20131223-02. — View Citation

Arnold RW, Clausen M, Ryan H, Leman RE, Armitage D. Predictive value of inexpensive digital eye and vision photoscreening: "PPV of ABCD". Binocul Vis Strabismus Q. 2007;22(3):148-52. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Braverman R. Diagnosis and treatment of refractive errors in the pediatric population. Curr Opin Ophthalmol. 2007 Sep;18(5):379-83. Review. — View Citation

Committee on Practice and Ambulatory Medicine and Section on Ophthalmology.; American Academy of Pediatrics.. Use of photoscreening for children's vision screening. Pediatrics. 2002 Mar;109(3):524-5. — View Citation

Courtright P, Hutchinson AK, Lewallen S. Visual impairment in children in middle- and lower-income countries. Arch Dis Child. 2011 Dec;96(12):1129-34. doi: 10.1136/archdischild-2011-300093. Review. — View Citation

Cummings GE. Vision screening in junior schools. Public Health. 1996 Nov;110(6):369-72. — View Citation

Donahue SP, Arthur B, Neely DE, Arnold RW, Silbert D, Ruben JB; POS Vision Screening Committee.. Guidelines for automated preschool vision screening: a 10-year, evidence-based update. J AAPOS. 2013 Feb;17(1):4-8. doi: 10.1016/j.jaapos.2012.09.012. — View Citation

Duong HV, Westfield KC, Jones LS, Mitchell J, Carr T. A survey of ocular diseases in an isolated rural Haitian community: a retrospective evaluation. J Natl Med Assoc. 2012 Nov-Dec;104(11-12):536-43. — View Citation

Eibschitz-Tsimhoni M, Friedman T, Naor J, Eibschitz N, Friedman Z. Early screening for amblyogenic risk factors lowers the prevalence and severity of amblyopia. J AAPOS. 2000 Aug;4(4):194-9. — View Citation

Fathy VC, Elton PJ. Orthoptic screening for three- and four-year-olds. Public Health. 1993 Jan;107(1):19-23. — View Citation

Jewell G, Reeves B, Saffin K, Crofts B. The effectiveness of vision screening by school nurses in secondary school. Arch Dis Child. 1994 Jan;70(1):14-8. — View Citation

Kedir J, Girma A. Prevalence of refractive error and visual impairment among rural school-age children of Goro District, Gurage Zone, Ethiopia. Ethiop J Health Sci. 2014 Oct;24(4):353-8. — View Citation

Kirk S, Armitage MD, Dunn S, Arnold RW. Calibration and validation of the 2WIN photoscreener compared to the PlusoptiX S12 and the SPOT. J Pediatr Ophthalmol Strabismus. 2014 Sep-Oct;51(5):289-92. doi: 10.3928/01913913-20140701-01. — View Citation

Krumholtz I. Results from a pediatric vision screening and its ability to predict academic performance. Optometry. 2000 Jul;71(7):426-30. Erratum in: Optometry. 2000 Aug;71(8):489. — View Citation

Kvarnström G, Jakobsson P, Lennerstrand G. Screening for visual and ocular disorders in children, evaluation of the system in Sweden. Acta Paediatr. 1998 Nov;87(11):1173-9. — View Citation

Kvarnström G, Jakobsson P, Lennerstrand G. Visual screening of Swedish children: an ophthalmological evaluation. Acta Ophthalmol Scand. 2001 Jun;79(3):240-4. — View Citation

Latorre-Arteaga S, Gil-González D, Enciso O, Phelan A, García-Muñoz A, Kohler J. Reducing visual deficits caused by refractive errors in school and preschool children: results of a pilot school program in the Andean region of Apurimac, Peru. Glob Health Action. 2014 Feb 13;7:22656. doi: 10.3402/gha.v7.22656. — View Citation

Lennerstrand G, Jakobsson P, Kvarnström G. Screening for ocular dysfunction in children: approaching a common program. Acta Ophthalmol Scand Suppl. 1995;(214):26-38; discussion 39-40. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Shamanna BR, Dandona L, Rao GN. Economic burden of blindness in India. Indian J Ophthalmol. 1998 Sep;46(3):169-72. — View Citation

Sharma A, Congdon N, Patel M, Gilbert C. School-based approaches to the correction of refractive error in children. Surv Ophthalmol. 2012 May-Jun;57(3):272-83. doi: 10.1016/j.survophthal.2011.11.002. Review. — View Citation

Silbert DI, Matta NS. Performance of the Spot vision screener for the detection of amblyopia risk factors in children. J AAPOS. 2014 Apr;18(2):169-72. doi: 10.1016/j.jaapos.2013.11.019. — View Citation

Snowdon SK, Stewart-Brown SL. Preschool vision screening. Health Technol Assess. 1997;1(8):i-iv, 1-83. Review. — View Citation

Sommer A, Toureau S, Cornet P, Midy C, Pettiss ST. Xerophthalmia and anterior segment blindness. Am J Ophthalmol. 1976 Sep;82(3):439-46. — View Citation

US Preventive Services Task Force.. Vision screening for children 1 to 5 years of age: US Preventive Services Task Force Recommendation statement. Pediatrics. 2011 Feb;127(2):340-6. doi: 10.1542/peds.2010-3177. — View Citation

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

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. — View Citation

Williams C, Northstone K, Harrad RA, Sparrow JM, Harvey I; ALSPAC Study Team.. Amblyopia treatment outcomes after preschool screening v school entry screening: observational data from a prospective cohort study. Br J Ophthalmol. 2003 Aug;87(8):988-93. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	7 days	No
Secondary	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.	7 days	No
Secondary	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.	7 days	No