Seeing to Learn in Sierra Leone

Refractive Errors Clinical Trial

— SLII  

Official title:

Seeing to Learn in Sierra Leone: Impact of Spectacle Correction on Children's Academic Performance and Mental Health Wellbeing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065631
• Other study ID #: Glewwe Transfer
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: Paul Glewwe, PhD
• Phone: +1 612 625 0225
• Email: pglewwe[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Eyeglasses
Children with uncorrected/under-corrected refractive error will be provided with either ready made or custom eyeglasses based on their magnitude and types of refractive errors.

Other:
• Prescription slip
Children with uncorrected/under-corrected refractive error will be provided with an eyeglasses prescription and letter to parents, but all of them will get eyeglasses at the end of the trial

Locations

Country	Name	City	State
Sierra Leone	Innovations for Poverty Action (IPA)	Freetown

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Innovations for Poverty Action, Peek Vision, Vision Action

Country where clinical trial is conducted

Sierra Leone, 

References & Publications (10)

Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston — View Citation

Dandona L, Dandona R. What is the global burden of visual impairment? BMC Med. 2006 Mar 16;4:6. doi: 10.1186/1741-7015-4-6. — View Citation

GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease S — View Citation

Glewwe 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. — View Citation

Keil S, Fielder A, Sargent J. Management of children and young people with vision impairment: diagnosis, developmental challenges and outcomes. Arch Dis Child. 2017 Jun;102(6):566-571. doi: 10.1136/archdischild-2016-311775. Epub 2016 Nov 16. — View Citation

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: 10.1 — View Citation

Ma 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. — View Citation

Naidoo 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. — View Citation

Wang X, Yi H, Lu L, Zhang L, Ma X, Jin L, Zhang H, Naidoo KS, Minto H, Zou H, Rozelle S, Congdon N. Population Prevalence of Need for Spectacles and Spectacle Ownership Among Urban Migrant Children in Eastern China. JAMA Ophthalmol. 2015 Dec;133(12):1399- — View Citation

Williams 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foundational mathematic and literacy skills	Item Response Theory to estimate a student's ability on a continuous scale and subsequently standardize students' scores on a continuous scale with respect to the control-group distribution at baseline (mean zero, standard deviation of one). Lower scores will indicate lower performance, and higher scores will indicate higher performance. A -1 would indicate a student's performance is 1 standard deviation below the mean of the control-group performance distribution at baseline. A zero would mean the student performed like the mean student in the control group at baseline.	Month 1 and 9 months after glasses are provided
Primary	Anxiety	Measured using Generalized Anxiety Disorder 2-item (GAD-2) questionnaire, the highest score is 8 and the lowest score is 2. Higher scores indicated more severe anxiety disorders.	Month 1 and 9 months after glasses are provided
Primary	Prosocial	Measured using Strengths & Difficulties Questionnaire with the prosocial score ranges from 0 to 10 and higher scores indicate more prosocial behaviour.	Month 1 and 9 months after glasses are provided
Primary	Social and emotional problems	Measured using Strengths & Difficulties Questionnaire with the score ranges from 0 to 40. Higher scores indicate more social and emotional problems.	Month 1 and 9 months after glasses are provided
Secondary	Teacher-observed wearing of eyeglasses of children	Proportion of children observed wear across all children at daily assessments	Month 1 to Month 9 after glasses are provided
Secondary	Self-reported wearing of eyeglasses compliance	Proportion of children who reported to be wearing their eyeglasses 1. Not at all 2. Sometimes 3. Most of the time 4. All the time	Month 9 after glasses are provided
Secondary	Enumerator-observed wearing of eyeglasses	Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination	At Months 3, 6 and 9 after glasses are provided
Secondary	Cost-effectiveness 1	Total eyeglasses distribution cost (excluding study cost) per child receiving, and wearing, eyeglasses at endline	Through study completion, an average of 9 months
Secondary	Cost-effectiveness 2	Total eyeglasses distribution cost (excluding study cost) per 0.1 standard deviation test score gain	Through study completion, an average of 9 months
Secondary	School attendance	Attendance data will be collected from attendance registry at school. This will be expressed in percentage. Lowest attendance being 0%, highest being 100%.	Daily from Month 1 to Month 9