HyperopiaZEALNCT05538182
Zimbabwe Eyecare And Learning(ZEAL):Formative Research on Hyperopia and Educational Outcomes in Primary School Children
A study testing Spectacles in people with Hyperopia and Long Sight, run by Queen's University, Belfast at 1 site in Zimbabwe.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia, Long Sight
- What is being tested?
- Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,883 participants
- Where
- 1 siteZimbabwe
- Study dates
- 1 Sep 2022to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
The University of Zimbabwe, Faculty of Medicine and Healthcare Sciences
Harare, P.O. Box A178
About this study
Official title: Zimbabwe Eyecare And Learning: Formative Research on Hyperopia and Educational Outcomes in Primary School Children in Mashonaland Central Province of Zimbabwe
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.
Read the 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.
- Conditions
- Hyperopia, Long Sight
- Being tested
- Spectacles
- Keywords
- Refractive error, Spectacle correction, Eyeglasses, Learning, School children
- Medical subject headings
- Hyperopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesDevice
Based on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles.
| Study group | Role | What they receive |
|---|---|---|
| Spectacles | Experimental | 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. Receives: Device: Spectacles |
| No treatment | No intervention | Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Measured at week 6 and week 14 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Sep 2022
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,883 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Nathan Congdon, Queen's University, Belfast
- Investigators
- Nathan G Congdon, MD, MPH, Principal investigator, Queen's University, BelfastRohit C Khanna, MPH, Principal investigator, L.V. Prasad Eye InstituteLynett E Masiwa, MSc, Principal investigator, University of ZimbabweRangarirai Masanganise, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538182
- Sponsor's protocol ID
- MHLS 22_63
- Acronym
- ZEAL
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 25249453Ma 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.
PubMed 29801081Glewwe 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.22043.
PubMed 29693366Narayanasamy 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.
PubMed 25525890Naidoo 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.
PubMed 12939289O'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.
PubMed 20494909French 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.
PubMed 22562516Hashemi 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.
PubMed 29564404Babinsky 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.
PubMed 23883788VIP-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.
PubMed 26826748Shankar 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.
PubMed 18043422Rosner 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.
PubMed 9354056Williams 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.
PubMed 15665167Atkinson 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.
PubMed 17299337Glewwe 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimbabwe Eyecare And Learning: Formative Research on Hyperopia and Educational Outcomes in Primary School Children in Mashonaland Central Province of Zimbabwe
- ClinicalTrials.gov ID
- NCT05538182
- Acronym / sponsor ID
- ZEAL / MHLS 22_63
- Conditions
- Hyperopia, Long Sight
- Keywords
- Refractive error, Spectacle correction, Eyeglasses, Learning, School children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,883 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- 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
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spectacles | Experimental | Device: SpectaclesBased 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. |
| No treatment | No intervention | –Age-, gender- and school-matched emmetropic controls will undergo a reading assessment at baseline and at six months. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpectaclesBased on the refraction results, study participants diagnosed with refractive error will be dispensed two free pairs of distance spectacles. | Device | Spectacles |
Primary outcome
Prevalence of moderate to high hyperopia (≥ +2.00D)
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
Binocular near visual acuity
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.
Accommodative response
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.
Presence of eye conditions
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.
Stereoacuity
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
Improvement in near visual acuity on prescribing hyperopic spectacle correction
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.
Change of reading scores 6 months post hyperopia spectacle correction
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
Observed spectacle wear
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 25249453Ma 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.
- Background: PubMed 29801081Ma 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.
- Background: PubMed 29693366Glewwe 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.22043.
- Background: PubMed 25525890Narayanasamy 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.
- Background: PubMed 12939289Naidoo 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.
- Background: PubMed 20494909O'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.
- Background: PubMed 22562516French 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.
- Background: PubMed 29564404Hashemi 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.
- Background: PubMed 23883788Babinsky 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.
- Background: PubMed 26826748VIP-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.
- Background: PubMed 18043422Shankar 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.
- Background: PubMed 9354056Rosner 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.
- Individual participant dataSharing planned: 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.
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Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan G Congdon, MD, MPH principal investigator
Queen's University, Belfast
Rohit C Khanna, MPH principal investigator
L.V. Prasad Eye Institute
Lynett E Masiwa, MSc principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles in people with Hyperopia and Long Sight, run by Queen's University, Belfast at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of moderate to high hyperopia (≥ +2.00D) (time frame: Measured at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538182, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.