Phase
Condition
Myopia
Eye Disorders/infections
Eye Disease
Treatment
Spectacles
Clinical Study ID
Ages 6-11 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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).
Study Design
Study Description
Connect with a study center
The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences
Harare, P.O. Box A178
ZimbabweSite Not Available
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