Clinical trial NCT06065631: Seeing to Learn in Sierra Leone
Official title: Seeing to Learn in Sierra Leone: Impact of Spectacle Correction on Children's Academic Performance and Mental Health Wellbeing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractive Errors
Keywords: Myopia
Hyperopia
Spectacle correction
Educational outcomes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
name: Peek Vision
name: Vision Action
First posted: 2023-10-04
Enrollment: 2400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eligible children will be randomized by school to receive at the start of the school year either: free ready-made or custom eyeglasses (Intervention), or an eyeglasses prescription and letter to parents, with free eyeglasses at endline (Control). The clusters (schools) will be stratified into groups based on the prevalence of refractive error and on the score on the baseline mathematics and reading exams. The division of the sample into schools in the two cities (Bo and Freetown) will be in the same proportion as the proportion of the number of public schools in those two cities.
Primary purpose: TREATMENT

Brief summary: The main objective of the Sierra Leone Sees to Learn (SL2) trial is to assess the educational impact of providing free eyeglasses to students aged 12-15 years with uncorrected refractive error in Sierra Leone. The procedures include baseline questionnaires and educational assessments to collect data on students and schools, and then the provision of free eyeglasses to students who have uncorrected (or undercorrected) refractive error (URE). The questionnaires and student assessments will take 1-2 hours. The duration of the study timeframe is one school year. The end-line questionnaires and student assessments will be administered at the end of the school year.

Detailed description: Objective: The main objective of the Sierra Leone Sees to Learn (SL2) trial is to assess the educational impact of providing free eyeglasses to students aged 12-15 years with uncorrected refractive error in Sierra Leone.

Sample frame: Approximately 2400 children with uncorrected (or undercorrected) refractive error (URE) at 160 randomly-selected schools in Freetown and Bo City. A similar number of children from the same schools but without vision problems will also be included, at baseline only, to compare their basic demographic characteristics and daily activities to those of the children with URE. The sample size may vary depending on the percentage of children with URE obtained from screening a total of 40,000 children. All children with URE as specified in the enrolment criteria below will be part of the study.

Design: Cluster-randomized control trial (cluster RCT), with schools as clusters.

Randomization, interventions and balancing: All eligible children will be randomized by school to receive at the start of the school year either: free ready-made or custom eyeglasses (Intervention), or an eyeglasses prescription and letter to parents, with free eyeglasses at end-line (Control). The clusters (schools) will be stratified into groups based on the prevalence of refractive error and on the score on the baseline mathematics and reading exams. The division of the sample into schools in the two cities (Bo and Freetown) will be in the same proportion as the proportion of the number of public schools in those two cities.

Power calculations (reading and math exams): Setting power = 0.8, statistical precision = 0.05, intracluster correlation = 0.2 (from 2019 Sierra Leone grade 8 learning assessment), 80 treated schools, 80 control schools, 15 students/school with uncorrected error, yields the following minimal detectable effect (MDE) sizes as a function of correlation between baseline and end-line tests:

MDE Correlation of baseline and end-line tests 0.101 0.7 0.127 0.6 0.148 0.5

A nested focus-group study will explore children's, parents' and teachers' attitudes towards vision, student learning, and wearing of eyeglasses, in order to design a locally-tailored intervention to promote wearing of eyeglasses.

Regression Framework:

The investigators will estimate the effect of the program using a single difference cross-sectional ordinary least squares regression (OLS), and a difference-in-difference (DID) OLS regression that includes observations at both end-line and baseline. The investigators will report two types of effects: the intent-to-treat (ITT) effects and local average treatment effects (LATE), using treatment assignment as an instrumental variable for participation. Analysis will use the observed baseline characteristics as control variables and account for school-level variation through a fixed effect.

Eligibility criteria: Inclusion Criteria:

1. Presenting (with or without glasses) distance visual acuity of 6/12 or worse in the better-seeing eye;
2. Refractive error of at least 0.75 diopters (D) of myopia, 2.00 D of hyperopia or 1.00 D of astigmatism;
3. Visual acuity is correctable to 6/7.5 or better with eyeglasses.

Exclusion Criteria:

1. Other ocular problems preventing visual acuity \> 6/12 in both eyes.

Primary outcomes:
measure: Foundational mathematic and literacy skills
timeFrame: Month 1 and 9 months after glasses are provided
measure: Anxiety
timeFrame: Month 1 and 9 months after glasses are provided
measure: Prosocial
timeFrame: Month 1 and 9 months after glasses are provided
measure: Social and emotional problems
timeFrame: Month 1 and 9 months after glasses are provided
Secondary outcomes:
measure: Teacher-observed wearing of eyeglasses of children
timeFrame: Month 1 to Month 9 after glasses are provided
measure: Self-reported wearing of eyeglasses compliance
timeFrame: Month 9 after glasses are provided
measure: Enumerator-observed wearing of eyeglasses
timeFrame: At Months 3, 6 and 9 after glasses are provided
measure: Cost-effectiveness 1
timeFrame: Through study completion, an average of 9 months
measure: Cost-effectiveness 2
timeFrame: Through study completion, an average of 9 months
measure: School attendance
timeFrame: Daily from Month 1 to Month 9
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Innovations for Poverty Action (IPA)
Study officials:
affiliation: Queen's University, Belfast
name: Nathan Congdon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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