Seeing to Learn in Sierra Leone

NCT06065631 | Terminated DMC

• 1 other identifier: Glewwe Transfer
• Study Type: interventional
• Target: 1,821
• Locations: 1 country
• Sites: 1

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 9-20 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.

Conditions

Refractive Errors

Keywords

Myopia; Hyperopia; Spectacle correction; Educational outcomes

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Teacher-observed wearing of eyeglasses of children

  Month 1 to Month 9 after glasses are provided

• Self-reported wearing of eyeglasses compliance

  Month 9 after glasses are provided

• Enumerator-observed wearing of eyeglasses

  At Months 3, 6 and 9 after glasses are provided

• Cost-effectiveness 1

  Through study completion, an average of 9 months

• Cost-effectiveness 2

  Through study completion, an average of 9 months

Study Arms (2)

Control

OTHER

An eyeglasses prescription and letter to parents, with free eyeglasses at endline.

Other: Prescription slip

Intervention

EXPERIMENTAL

free ready-made or custom eyeglasses

Device: Eyeglasses

Interventions

Eyeglasses DEVICE

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.

Also known as: Glasses, Spectacle

Intervention

Prescription slip OTHER

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

Control

Eligibility Criteria

• Age: 9 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• Innovations for Poverty Action: collaborator
• Peek Vision: collaborator
• Vision Action: collaborator

Study Sites (1)

Innovations for Poverty Action (IPA)

Freetown, Sierra Leone

Location

Related Publications (10)

• 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 Study. Lancet Glob Health. 2021 Feb;9(2):e130-e143. doi: 10.1016/S2214-109X(20)30425-3. Epub 2020 Dec 1.

  PMID: 33275950 RESULT

• 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 AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.

  PMID: 33607016 RESULT

• 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.

  PMID: 16539747 RESULT

• 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.22043.

  PMID: 29693366 RESULT

• 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.

  PMID: 27852581 RESULT

• 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.

  PMID: 25249453 RESULT

• 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.

  PMID: 12939289 RESULT

• 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: 10.1001/jamaophthalmol.2018.1329.

  PMID: 29801081 RESULT

• 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):1399-406. doi: 10.1001/jamaophthalmol.2015.3513.

  PMID: 26426113 RESULT

• 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.

  PMID: 15665167 RESULT

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Nathan Congdon, MD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be given either glasses or a prescription. Hence, they could not be masked. The Care Provider, in our case, screening and examination team will be providing either glasses or prescriptions to the participants. Hence, they could not masked. Investigators and Outcome assessor will only analyse the data at the end of the trial and they will not be
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 4, 2023
• Study Start: October 25, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available once they are cleaned and de-identified, kept for at least 10 years after study completion
• Access Criteria: Those who wish to access the de-identified data will need to request formally with the research team.

Locations

SI (1)