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Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children (ZEAL)

Primary Purpose

Hyperopia, Long Sight

Status
Recruiting
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Spectacles
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Refractive error, Spectacle correction, Eyeglasses, Learning, School children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria for the cross-sectional assessment of hyperopia prevalence and diagnostic tool development evaluation:

  • Grades 2 or 4 from the list of selected primary schools by the Ministry of Primary and Secondary Education (MoPSE)

Inclusion criteria for the baseline and longitudinal assessment of reading performance

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 for the baseline and longitudinal assessment of reading performance and spectacle compliance.

Children in either cohort will be ineligible if they have:

  • 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).

Sites / Locations

  • The University of Zimbabwe, Faculty of Medicine and Healthcare SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Spectacles

No treatment

Arm Description

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.

Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.

Outcomes

Primary Outcome Measures

Prevalence of moderate to high hyperopia (≥ +2.00D)
The metric or method of measurement to be used:The Average of three readings(in dioptre)using cycloplegic autorefraction for each eye. Higher dioptre indicates high hyperopia
Binocular near visual acuity
The metric or method of measurement to be used: Logarithm of Minimum Angle of Resolution(LogMAR) measured using the laser-etched near vision chart with Lea symbols at 12.5 cm.
Accommodative response
The metric or method of measurement to be used: binocular distance autorefraction measured at 3 metres and monocular near refraction measured at 25cm using the Quick See autorefractor.
Presence of eye conditions
The metric or method of measurement to be used: assessing the overall appearance of the fundus reflex in both eyes(Bruckner Reflex Test) as an indicator of the prevalence of refractive error using the Arclight ophthalmoscope. This will be a binary outcome of Yes or No.
Stereoacuity
The metric or method of measurement to be used: measured in seconds of arc using the Preschool Assessment of Stereopsis with a Smile (PASS) 3+ stereoacuity test (scores: 480, 240, 120, 60, 40 and 30). Seconds of arc refers to the visual angle being measured to determine depth perception. Lower scores indicate better stereoacuity. Highest possible score: 480 Lowest possible score: 30
Improvement in near visual acuity on prescribing hyperopic spectacle correction
The metric or method of measurement to be used: measured in M-unit using a conventional near vision chart with Lea symbols at 40cm.
Change of reading scores 6 months post hyperopia spectacle correction
The metric or method of measurement to be used: Reading scores measured using the Happy Readers V4 reading test. Best possible score: Improvement from baseline Worst possible score: No change from baseline
Observed spectacle wear
The metric or method of measurement to be used: proportion of children prescribed with spectacles, wearing them during unannounced direct observation

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
February 14, 2023
Sponsor
Queen's University, Belfast
Collaborators
L.V. Prasad Eye Institute, University of Zimbabwe, University of Ulster, New England College of Optometry, Peek Vision, Zimbabwe Optometric Association, Clearly, Christian Blind Mission
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1. Study Identification

Unique Protocol Identification Number
NCT05538182
Brief Title
Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children
Acronym
ZEAL
Official Title
Zimbabwe Eyecare And Learning: Formative Research on Hyperopia and Educational Outcomes in Primary School Children in Mashonaland Central Province of Zimbabwe
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
L.V. Prasad Eye Institute, University of Zimbabwe, University of Ulster, New England College of Optometry, Peek Vision, Zimbabwe Optometric Association, Clearly, Christian Blind Mission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether uncorrected or corrected long-sightedness (hyperopia) has an impact on reading skills, in Grade 2 or Grade 4 school-aged children from Mashonaland Central province of Zimbabwe, compared to age-, gender- and school-matched children with no refractive error (emmetropia), measured by the Happy Readers V4 reading tool over six months.
Detailed Description
Trials in Asia have shown that correction of myopia (close-sightedness) in children has improved educational performance with an effect size larger than for any other school-based health intervention. Myopia prevalence which is, generally inversely associated with the prevalence of hyperopia, appears low in African children. Globally, uncorrected hyperopia (long-sightedness) has a higher prevalence and is present in 12-26% of children, depending on location and age, but the impact of its correction on educational outcomes is not well understood. All-age prevalence of hyperopia is higher in Africa than in any other global region. Despite the traditional view that moderate hyperopia is generally benign, emerging evidence suggests that even moderate uncorrected hyperopia is associated with reduced near function, poorer educational outcomes and lower reading scores. A recent trial in the USA showed that providing refractive correction improved reading scores but did not distinguish between myopia and hyperopia. Another trial in the USA found only small benefits from refractive correction in 1- to 2-year-olds. However, no trial to date has studied the educational impact of hyperopic correction in school-aged children with +2.00 Dioptres (D) or more of hyperopia. 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: 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. To accurately detect moderate to high hyperopia (≥ +2.00D) using four screening tests compared to the gold-standard cycloplegic refraction. 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: 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. To compare spectacle compliance among newly diagnosed hyperopic and newly diagnosed myopic (short-sighted) school children at six weeks and 14 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Long Sight
Keywords
Refractive error, Spectacle correction, Eyeglasses, Learning, School children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children in Grade 2 and 4 at 16 randomly-selected primary schools in Mashonaland Central province of Zimbabwe will receive free glasses as described in the protocol.
Masking
Outcomes Assessor
Masking Description
For the following objectives, all tests will be conducted by trained researchers who will be masked to the hyperopia status of the children: Prevalence of moderate to high hyperopia (>+2.00D in the more hyperopic meridian, in the more hyperopic eye, using cycloplegic autorefraction). The diagnostic accuracy of four screening tools for detecting hyperopia compared to the gold standard of cycloplegic refraction. 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.
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spectacles
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.
Intervention Type
Device
Intervention Name(s)
Spectacles
Intervention Description
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
Primary Outcome Measure Information:
Title
Prevalence of moderate to high hyperopia (≥ +2.00D)
Description
The metric or method of measurement to be used:The Average of three readings(in dioptre)using cycloplegic autorefraction for each eye. Higher dioptre indicates high hyperopia
Time Frame
Measured at baseline
Title
Binocular near visual acuity
Description
The metric or method of measurement to be used: Logarithm of Minimum Angle of Resolution(LogMAR) measured using the laser-etched near vision chart with Lea symbols at 12.5 cm.
Time Frame
Measured at baseline
Title
Accommodative response
Description
The metric or method of measurement to be used: binocular distance autorefraction measured at 3 metres and monocular near refraction measured at 25cm using the Quick See autorefractor.
Time Frame
Measured at baseline
Title
Presence of eye conditions
Description
The metric or method of measurement to be used: assessing the overall appearance of the fundus reflex in both eyes(Bruckner Reflex Test) as an indicator of the prevalence of refractive error using the Arclight ophthalmoscope. This will be a binary outcome of Yes or No.
Time Frame
Measured at baseline
Title
Stereoacuity
Description
The metric or method of measurement to be used: measured in seconds of arc using the Preschool Assessment of Stereopsis with a Smile (PASS) 3+ stereoacuity test (scores: 480, 240, 120, 60, 40 and 30). Seconds of arc refers to the visual angle being measured to determine depth perception. Lower scores indicate better stereoacuity. Highest possible score: 480 Lowest possible score: 30
Time Frame
Measured at baseline
Title
Improvement in near visual acuity on prescribing hyperopic spectacle correction
Description
The metric or method of measurement to be used: measured in M-unit using a conventional near vision chart with Lea symbols at 40cm.
Time Frame
Measured at baseline,2 weeks and 24 weeks after baseline
Title
Change of reading scores 6 months post hyperopia spectacle correction
Description
The metric or method of measurement to be used: Reading scores measured using the Happy Readers V4 reading test. Best possible score: Improvement from baseline Worst possible score: No change from baseline
Time Frame
Measured at baseline and at month -6
Title
Observed spectacle wear
Description
The metric or method of measurement to be used: proportion of children prescribed with spectacles, wearing them during unannounced direct observation
Time Frame
Measured at week 6 and week 14 from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for the cross-sectional assessment of hyperopia prevalence and diagnostic tool development evaluation: Grades 2 or 4 from the list of selected primary schools by the Ministry of Primary and Secondary Education (MoPSE) Inclusion criteria for the baseline and longitudinal assessment of reading performance 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 for the baseline and longitudinal assessment of reading performance and spectacle compliance. Children in either cohort will be ineligible if they have: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan G Congdon, MD, MPH
Phone
+44(0)2890978929
Ext
8929
Email
n.congdon@qub.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Rohit C Khanna, MPH
Phone
+9914035225600
Ext
5600
Email
rohit@lvpei.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan G Congdon, MD, MPH
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohit C Khanna, MPH
Organizational Affiliation
L.V. Prasad Eye Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynett E Masiwa, MSc
Organizational Affiliation
University of Zimbabwe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rangarirai Masanganise
Organizational Affiliation
University of Zimbabwe
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences
City
Harare
ZIP/Postal Code
P.O. Box A178
Country
Zimbabwe
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynett E Masiwa, MSc
Phone
+263773596419
Email
lemasiwa@eyedohc.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Participant Data (IPD) will be stored in an anonymised format. The IPD that includes personally identifiable information will be deleted when the data collection process is complete and before the initiation of data analysis. Only de-identified data will be shared with all the researchers for analysis. The primary analysis will be conducted on all outcome data obtained from all enrolled participants as randomised.
IPD Sharing Time Frame
All deidentified IPD will be available from June 2022 (anticipated Trial start date) to December 2032 (inclusive of analysis, publication and archival).
IPD Sharing Access Criteria
Following publication of the primary outcomes there may be scope to conduct additional analyses on the data collected. In such instances formal requests for data will need to be made in writing to the Chief Investigator, who will discuss this with the Sponsor. The study will comply with the good practice principles for sharing individual participant data from publicly funded clinical trials and data sharing will be undertaken in accordance with the required regulatory requirements.
Citations:
PubMed Identifier
25249453
Citation
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.
Results Reference
background
PubMed Identifier
29801081
Citation
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.
Results Reference
background
PubMed Identifier
29693366
Citation
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.
Results Reference
background
PubMed Identifier
25525890
Citation
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.
Results Reference
background
PubMed Identifier
12939289
Citation
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.
Results Reference
background
PubMed Identifier
20494909
Citation
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.
Results Reference
background
PubMed Identifier
22562516
Citation
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.
Results Reference
background
PubMed Identifier
29564404
Citation
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.
Results Reference
background
PubMed Identifier
23883788
Citation
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.
Results Reference
background
PubMed Identifier
26826748
Citation
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.
Results Reference
background
PubMed Identifier
18043422
Citation
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.
Results Reference
background
PubMed Identifier
9354056
Citation
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.
Results Reference
background
PubMed Identifier
15665167
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. doi: 10.1136/adc.2003.046755.
Results Reference
background
PubMed Identifier
17299337
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. doi: 10.1097/OPX.0b013e318031b69a.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children

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