The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences
Harare, P.O. Box A178, Zimbabwe
NCT Number: NCT05538182
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.
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Notify Me6 year–11 year
All sexes
Interventional
Not applicable
Harare, P.O. Box A178, Zimbabwe
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:
Objectives 4 and 5 use a longitudinal intervention design to assess the following:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the cross-sectional assessment of hyperopia prevalence and diagnostic tool development evaluation:
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:
Emmetropic cohort:
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:
Myopic cohort:
Exclusion criteria
for the baseline and longitudinal assessment of reading performance and spectacle compliance.
Children in either cohort will be ineligible if they have:
Children in the hyperopic cohort will be ineligible if they have:
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
Time frame: Measured at baseline
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
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
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
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
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,2 weeks and 24 weeks after baseline
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 and at month -6
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 week 6 and week 14 from baseline
The metric or method of measurement to be used: proportion of children prescribed with spectacles, wearing them during unannounced direct observation
Queen's University, Belfast
Other
Zimbabwe Eyecare And Learning: Formative Research on Hyperopia and Educational Outcomes in Primary School Children in Mashonaland Central Province of Zimbabwe
Acronym: ZEAL
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