An interventional study of Spectacles in Hyperopia and Long Sight, sponsored by Queen's University, Belfast. Completed at 1 site in Zimbabwe. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Treatment
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.
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 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:
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's enrollment of 1,883 is above the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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, 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.
Device: Spectacles
Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months.
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
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
Time frame: Measured at baseline
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.
Time frame: Measured at baseline
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.
Time frame: Measured at baseline
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.
Time frame: Measured at baseline
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
Time frame: Measured at baseline
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.
Time frame: Measured at baseline,2 weeks and 24 weeks after baseline
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
Time frame: Measured at baseline and at month -6
Observed spectacle wear
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
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: All deidentified IPD will be available from publication of the primary results until 10 years after the end of the trial.
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.
Ran from Sep 2022 to primary completion in Jul 2023, 10 months.
Of 54 interventional studies with no phase under Hyperopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 24. This study's 10 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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