Zimbabwe Eyecare And Learning: Formative Research on Hyperopia and Educational Outcomes in Primary School Children in Mashonaland Central Province of Zimbabwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,883
- 试验地点
- 1
- 主要终点
- Stereoacuity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Spectacles (Device)
No treatment
Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.
结局指标
主要结局
Stereoacuity
时间窗: 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
Presence of eye conditions
时间窗: 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.
Prevalence of moderate to high hyperopia (≥ +2.00D)
时间窗: 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
Binocular near visual acuity
时间窗: 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.
Improvement in near visual acuity on prescribing hyperopic spectacle correction
时间窗: 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.
Accommodative response
时间窗: 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.
Change of reading scores 6 months post hyperopia spectacle correction
时间窗: 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
Observed spectacle wear
时间窗: 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
次要结局
未报告次要终点
研究者
Nathan Congdon
Professor
Queen's University, Belfast
