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Trial record 75 of 1373 for:    rural

Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities (SWISH)

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ClinicalTrials.gov Identifier: NCT04077086
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Stanford University
New England College of Optometry
Clearly
Ningxia Medical University
Information provided by (Responsible Party):
Nathan Congdon, Queen's University, Belfast

Brief Summary:

Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already shown in other trials that giving children free glasses leads to better grades and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural western China goes on to a regular, non-vocational high school. The investigators would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them.

Study Plan: The investigators will choose 130 middle schools at random in Ningxia, western China, and all children in Years 1 and 2 (one class each) at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses ("Intervention") or a group getting just glasses prescriptions ("Control.") The main study outcome will be the proportion of children going on to academic (as opposed to vocational) high school, and the study is powered to detect a 10% difference in this figure between groups.The study will also assess children's test scores, whether they wear their glasses at school, and how often they use blackboards (which disadvantage short-sighted children) vs textbooks to learn from. These other outcomes will help us to better understand the causal pathway between vision and high school attendance. We will also study the total cost of providing glasses glasses and the teacher support to wear them per additional student attending academic high school. The hypothesis of this study is that providing glasses will increase academic high school attendance.


Condition or disease Intervention/treatment Phase
Refractive Errors Device: Spectacles Not Applicable

Detailed Description:

Research question: Will providing free glasses to myopic rural Chinese students, with a teacher incentive to promote use, increase academic high school attendance?

Design: Cluster-randomised controlled trial

Rationale: Rural Chinese children have high myopia prevalence, but poor access to glasses. Our previous trials show giving free glasses significantly improves academic performance, with greater effect size than parental education or family income, equaling or exceeding other classroom-based medical interventions. Non-vocational (academic) high school attendance is only 30% in rural western China. Strong evidence of educational benefit from glasses is needed to spur adoption of national distribution programs.

Methods: Children in Year 1 and 2 (1 class each) at 130 randomly-selected middle schools in Ningxia, western China, will be randomized by school to receive free glasses and a trial-proven teacher-based incentive to promote wear (Intervention) or prescriptions only (Control). The main outcome 2-3 years later will be high school attendance (powered to detect 10% difference between study groups); secondary outcomes of compliance, test scores and use of near versus distance classroom learning aids will elucidate biological plausibility of a causal pathway between myopia correction and learning. Local knowledge and attitudes about myopia and spectacle use and intervention cost-effectiveness will be studied.

Statistical methods to be employed in the analysis and justification for the choice of sample size:

Adjusted- and unadjusted-comparison of the difference between study groups

  • Of academic high school attendance
  • of mathematics test performance at endline (adjusted for baseline),
  • of observed spectacle wear at un-announced examinations

Sample size: Assuming 50% of children will fail vision screening, 70% of these needing glasses, with loss to follow-up=10%, α=0.05, intra-class correlation=0.15, explained variation by covariates=0.40, difference between the groups in the main study outcome=10%, high-school attendance rate in the Control group=30%, a sample size of 130 middle-schools (65 in each group) will provide power=85%.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children in Year 1 and 2 at 130 randomly-selected middle-schools in Ningxia, western China, will be randomized by school to receive free glasses and a teacher-based incentive to promote wear, or prescriptions only.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Study personnel assessing trial outcomes will be masked as to children's study group assignment, which will be simplified by the fact that there will be participants with and without glasses at both Intervention and Control schools. It is not ethical in this setting to provide Control participants with placebo treatment (glasses with zero power lenses), but students, parents and teachers will not be informed of either the overall design of the study or the explicit treatment intervention assignment. Only one school will be selected in each township, minimizing the possibility of cross arm communication and contamination.
Primary Purpose: Treatment
Official Title: SWISH (See Well to Stay In ScHool): Randomised Trial of Spectacle Distribution to Secondary School Children With Myopia to Increase Academic High School Attendance Rates in Rural Communities)
Estimated Study Start Date : November 5, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if ≥80% of children given glasses are wearing them at the time of 2 unannounced class visits by study investigators, the teacher will receive a Chinese-made tablet computer.
Device: Spectacles
Intervention group children in middle school Years 1 and 2 will receive spectacles at the beginning of the academic year (September 2019). Assuming that the relevant effects of treatment (glasses wear) on the main study outcome are complete once examinations determining high school attendance are finished at the end of Middle School Year 3, Intervention participants will have undergone either 22 months (September 2019 to July 2021 for those recruited in Year 2) or 34 months (September 2019 to July 2022 for those recruited in Year 1) of treatment by the endpoint of the trial.
Other Name: Glasses

No Intervention: Control
Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. No teacher incentive will be offered. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China.



Primary Outcome Measures :
  1. Academic high school attendance [ Time Frame: In September following completion of Year 3 of Middle School. This occurs after 24 months of participant followup for children recruited in middle school Year 2 and after 36 months of participant followup for those recruited in middle school year 1. ]
    Proportion of children who continue to academic high school as opposed to vocational high school or no additional schooling, assessed by systematically contacting parents, teachers and students to ascertain enrolment status


Secondary Outcome Measures :
  1. Compliance with spectacle wear [ Time Frame: After 8, 20 and 32 months of participant followup ]
    Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination.

  2. Mathematics score [ Time Frame: After 8, 20 and 32 months of participant followup) ]
    Scores at the end of each school year on a study-specific mathematics test, adjusting for baseline score.

  3. Blackboard use [ Time Frame: After 20 and 32 months of participant followup ]
    Frequency of blackboard versus textbook use in the major subjects (Maths, Chinese, English) on a questionnaire administered to teachers, and answered as "all", "most", "about half", little" or "none" of teaching.

  4. Cost effectiveness of intervention. [ Time Frame: At study closeout, after 24 months of participant followup for those recruited in middle school Year 2 and 36 months of participant followup for those recruited in Middle School Year 1. ]
    Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control. Intervention costs will comprise the screening test, glasses (including replacements) and teacher incentives.

  5. Mental Health [ Time Frame: After 20 and 32 months of participant followup. ]
    Symptom Scores on the SElf-Reported, Chinese language version of the Strengths and Difficulties Questionnaire (SDQ), previously validated by Du et al 2008.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Year 1 and 2 classes (likely age 12-15 years) at the recruited schools
  • Have uncorrected (without glasses) visual acuity of ≤6/12 in either eye;
  • Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected (myopia ≤−0.75 diopters (D), hyperopia ≥2.00 D, or astigmatism (non-spherical refractive error) ≥1.00 D);
  • Visual acuity can be improved to >6/12 in both eyes with glasses.

Exclusion Criteria:

  • Presence of visually-significant ocular condition besides refractive error

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077086


Contacts
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Contact: Nathan Congdon, MD, MPH 07748751393 ncongdon1@gmail.com

Locations
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United Kingdom
Centre for Public Health
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Zhongshan Ophthalmic Center, Sun Yat-sen University
Stanford University
New England College of Optometry
Clearly
Ningxia Medical University
Investigators
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Principal Investigator: Nathan Congdon, MD, MPH Queen's University, Belfast

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Responsible Party: Nathan Congdon, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT04077086     History of Changes
Other Study ID Numbers: MR/S023208/1
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available on the websites of Queen's University Belfast and Stanford University
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 6 months of completing data analysis, available for 5 years.
Access Criteria: Open

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nathan Congdon, Queen's University, Belfast:
Refractive error
Myopia
Academic high school attendance
Education attainment
Spectacle wear compliance
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors