Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children
NCT ID: NCT05538182
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1883 participants
INTERVENTIONAL
2022-09-01
2023-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
NCT06714994
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
NCT05533450
Perceptual Learning Improve Visual Function in Patients With Keratoconus
NCT05220904
Correction of Anisometropic Amblyopia in Children.
NCT05325021
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
NCT06555367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
While the gold standard for detecting hyperopia in children during vision examinations requires cycloplegic eye drops to temporarily inhibit accommodation (focusing effort to see near objects), using these eye drops requires trained providers and clinical supervision. It is not typically feasible in vision screening settings. The Vision in Preschoolers study showed that two autorefractors (Retinomax, SureSight) and non-cycloplegic retinoscopy had high discriminatory power to detect young children with hyperopia. However, non-cycloplegic retinoscopy requires trained providers, SureSight is no longer commercially available, and the Retinomax is cost-prohibitive for many screening programs. This limits the availability of hyperopia prevalence data in African children, though, as noted above, available evidence suggests high rates. Most screening programmes use 6/12 as an optimal cut-off value for distance vision. However, studies have reported that measuring distance vision alone is ineffective in detecting hyperopia. Literacy rates remain particularly low among primary school children in sub-Saharan Africa compared to other regions. The challenges and importance of maximising children's early learning, and the potentially important role of vision correction, are not well-understood in this setting. However, these initiatives have focused on myopia, not hyperopia.
Study plan: 2000 study participants (1000: Grade 2, 1000: Grade 4) will be recruited from primary schools selected by the Ministry of Primary and Secondary Education (MoPSE) in Mashonaland Central province in Zimbabwe.
Study design:
Objectives 1, 2 and 3 use a cross-sectional study design to assess the following:
1. To assess the prevalence of moderate to high hyperopia (≥ +2.00D) among primary school children in Grades 2 and 4 from Mashonaland Central province in Zimbabwe.
2. To accurately detect moderate to high hyperopia (≥ +2.00D) using four screening tests compared to the gold-standard cycloplegic refraction.
3. To study the association between uncorrected and corrected moderate to high hyperopia (≥ +2.00D) and baseline reading levels.
Objectives 4 and 5 use a longitudinal intervention design to assess the following:
4. To compare near visual acuity and reading levels at baseline and at six months between moderate to high hyperopic (≥ +2.00D) children compared to age-, gender-, and school-matched controls with no vision problems.
5. To compare spectacle compliance among newly diagnosed hyperopic and newly diagnosed myopic (short-sighted) school children at six weeks and 14 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
1. Prevalence of moderate to high hyperopia (\>+2.00D in the more hyperopic meridian, in the more hyperopic eye, using cycloplegic autorefraction).
2. The diagnostic accuracy of four screening tools for detecting hyperopia compared to the gold standard of cycloplegic refraction.
3. The cross-sectional association between uncorrected moderate to high hyperopia and baseline reading levels (using the Happy Readers V4 tool). We will compare the results to age-, gender-and school-matched emmetropic children.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spectacles
Based on the refraction results, spectacles will be prescribed at the baseline visit and worn throughout the study. Study participants with newly diagnosed hyperopia at baseline will undergo a reading assessment and near visual acuity check over six months, compared to age-, gender- and school-matched emmetropic controls.
Spectacle compliance will be observed among newly diagnosed hyperopic and newly diagnosed myopic school children in Grades 2 and 4 primary school children, from Mashonaland Central province of Zimbabwe, at six weeks and 14 weeks from spectacle acquisition.
Spectacles
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
No treatment
Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spectacles
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Primary school children will be eligible to participate in the 'reading assessment' if they fulfil the following criteria:
Hyperopic cohort:
* In Grade 2 or 4 from the list of selected schools by the MoPSE.
* Presence of moderate to high hyperopia, defined as ≥ +2.00D in the more hyperopic meridian, in the more hyperopic eye, using cycloplegic autorefraction with an average of three consecutive readings taken.
Emmetropic cohort:
* In Grade 2 or 4 from the list of selected schools by the MoPSE.
* Meets criteria for visually normal (unaided distance visual acuity 6/6 monocular and near visual acuity N5), based on an absence of significant refractive error.
* Presence of emmetropia, defined as \< +1.00D to \>-0.50 Dioptre in the more hyperopic meridian, in both eyes using cycloplegic autorefraction with an average of three consecutive readings taken to record the refractive status.
Newly diagnosed hyperopic and newly diagnosed myopic children will be eligible to participate in the 'spectacle compliance' assessment if they fulfil the following criteria:
Hyperopic cohort:
* Presence of hyperopia, defined as ≥ +2.00D in the more hyperopic meridian, in the more hyperopic eye by cycloplegic autorefraction.
Myopic cohort:
* Presence of myopia, defined as \<-0.50D in the more hyperopic meridian, in either eye by cycloplegic autorefraction.
Exclusion Criteria
* History of systemic disease or ocular disease and/or medications known to have an impact on accommodation.
* History of previous spectacle wear
Children in the hyperopic cohort will be ineligible if they have:
* Vision limitation in either eye for reasons other than hyperopia (including amblyopia defined as \<6/12 in the better eye).
6 Years
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
L.V. Prasad Eye Institute
OTHER
University of Zimbabwe
OTHER
University of Ulster
OTHER
New England College of Optometry
OTHER
Peek Vision
UNKNOWN
Zimbabwe Optometric Association
UNKNOWN
Clearly
OTHER
Christian Blind Mission
UNKNOWN
Queen's University, Belfast
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nathan Congdon
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nathan G Congdon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Rohit C Khanna, MPH
Role: PRINCIPAL_INVESTIGATOR
L.V. Prasad Eye Institute
Lynett E Masiwa, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Zimbabwe
Rangarirai Masanganise
Role: PRINCIPAL_INVESTIGATOR
University of Zimbabwe
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences
Harare, , Zimbabwe
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ma X, Zhou Z, Yi H, Pang X, Shi Y, Chen Q, Meltzer ME, le Cessie S, He M, Rozelle S, Liu Y, Congdon N. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial. BMJ. 2014 Sep 23;349:g5740. doi: 10.1136/bmj.g5740.
Ma Y, Congdon N, Shi Y, Hogg R, Medina A, Boswell M, Rozelle S, Iyer M. Effect of a Local Vision Care Center on Eyeglasses Use and School Performance in Rural China: A Cluster Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):731-737. doi: 10.1001/jamaophthalmol.2018.1329.
Glewwe P, West KL, Lee J. The Impact of Providing Vision Screening and Free Eyeglasses on Academic Outcomes: Evidence from a Randomized Trial in Title I Elementary Schools in Florida. J Policy Anal Manage. 2018;37(2):265-300. doi: 10.1002/pam.22043.
Narayanasamy S, Vincent SJ, Sampson GP, Wood JM. Impact of simulated hyperopia on academic-related performance in children. Optom Vis Sci. 2015 Feb;92(2):227-36. doi: 10.1097/OPX.0000000000000467.
Naidoo KS, Raghunandan A, Mashige KP, Govender P, Holden BA, Pokharel GP, Ellwein LB. Refractive error and visual impairment in African children in South Africa. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):3764-70. doi: 10.1167/iovs.03-0283.
O'Donoghue L, McClelland JF, Logan NS, Rudnicka AR, Owen CG, Saunders KJ. Refractive error and visual impairment in school children in Northern Ireland. Br J Ophthalmol. 2010 Sep;94(9):1155-9. doi: 10.1136/bjo.2009.176040. Epub 2010 May 21.
French AN, O'Donoghue L, Morgan IG, Saunders KJ, Mitchell P, Rose KA. Comparison of refraction and ocular biometry in European Caucasian children living in Northern Ireland and Sydney, Australia. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):4021-31. doi: 10.1167/iovs.12-9556.
Hashemi H, Fotouhi A, Yekta A, Pakzad R, Ostadimoghaddam H, Khabazkhoob M. Global and regional estimates of prevalence of refractive errors: Systematic review and meta-analysis. J Curr Ophthalmol. 2017 Sep 27;30(1):3-22. doi: 10.1016/j.joco.2017.08.009. eCollection 2018 Mar.
Babinsky E, Candy TR. Why do only some hyperopes become strabismic? Invest Ophthalmol Vis Sci. 2013 Jul 24;54(7):4941-55. doi: 10.1167/iovs.12-10670.
VIP-HIP Study Group; Kulp MT, Ciner E, Maguire M, Moore B, Pentimonti J, Pistilli M, Cyert L, Candy TR, Quinn G, Ying GS. Uncorrected Hyperopia and Preschool Early Literacy: Results of the Vision in Preschoolers-Hyperopia in Preschoolers (VIP-HIP) Study. Ophthalmology. 2016 Apr;123(4):681-9. doi: 10.1016/j.ophtha.2015.11.023. Epub 2016 Jan 27.
Shankar S, Evans MA, Bobier WR. Hyperopia and emergent literacy of young children: pilot study. Optom Vis Sci. 2007 Nov;84(11):1031-8. doi: 10.1097/OPX.0b013e318157a67a.
Rosner J, Rosner J. The relationship between moderate hyperopia and academic achievement: how much plus is enough? J Am Optom Assoc. 1997 Oct;68(10):648-50.
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.
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.
Glewwe P, Park A, Zhao M. A better vision for development: Eyeglasses and academic performance in rural primary schools in China. J Dev Econ. 2016;122:170-82.
White SLJ, Wood JM, Black AA, Hopkins S. Vision screening outcomes of Grade 3 children in Australia: Differences in academic achievement. Int J Educ Res. 2017;83:154-9.
Slavin RE, Collins ME, Repka MX, Friedman DS, Mudie LI, Owoeye JO, et al. In Plain Sight: Reading Outcomes of Providing Eyeglasses to Disadvantaged Children. J Educ Stud Placed Risk. 2018;23(3):250-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MHLS 22_63
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.