Effectiveness of Alternative Approaches to Providing Spectacles in Tanzanian Secondary School Students
Primary Purpose
Under- and Uncorrected Significant Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Under- and Uncorrected Significant Refractive Errors focused on measuring significant refractive errors, children, spectacles, Africa
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of un- or undercorrected significant refractive error form 1 student in participating secondary schools Exclusion Criteria: presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher
Sites / Locations
- Secondary Schools
Outcomes
Primary Outcome Measures
The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later
Secondary Outcome Measures
Full Information
NCT ID
NCT00249275
First Posted
November 3, 2005
Last Updated
November 3, 2005
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
British Council for Prevention of Blindness, Tanzanian Society for the Blind
1. Study Identification
Unique Protocol Identification Number
NCT00249275
Brief Title
Effectiveness of Alternative Approaches to Providing Spectacles in Tanzanian Secondary School Students
Official Title
Evaluation of the Effectiveness of Alternative Approaches to Providing Spectacles in Secondary School Students in Dar Es Salaam, Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
British Council for Prevention of Blindness, Tanzanian Society for the Blind
4. Oversight
5. Study Description
Brief Summary
The aim of this study was to compare the effectiveness of two interventions, namely providing free spectacles or only a prescription to students with insufficiently corrected or uncorrected significant refractive errors.
Detailed Description
Introduction Worldwide uncorrected significant refractive errors (RE) are among the commonest causes of visual impairment. This combined with the effectiveness and simplicity of correcting RE by providing spectacles has made the correction of RE one of the priorities of Vision 2020. However, little information is available on effective strategies for identifying and delivering optical services to affected individuals in developing countries
Aim The aim of this study was to compare the effectiveness of two interventions, namely providing free spectacles or only a prescription to students with insufficiently corrected or uncorrected significant refractive errors
Objectives
To estimate the prevalence and type of significant refractive errors in secondary school children in Tanzania, and to determine the unmet need for spectacles
To compare the effectiveness of providing free spectacles vs. offering only a prescription. This was judged as the proportion of students needing spectacles who were wearing spectacles at 3 and at 6 months after prescription
To explore attitudes to spectacles and reasons for non-compliance
Methods The study took place in Dar es Salaam, Tanzania between January and September 2004. 52 schools were randomly selected into 2 intervention groups (Group A and B) using random selection stratified by school status (government vs. private). Students were screened for significant refractive errors. A socio-economic questionnaire was administered to all the students. Students who needed spectacles in Group A schools received free spectacles (intervention A), while students in group B schools received only a prescription for spectacles (intervention B). Students were followed up 3 and 6 months after spectacles provision/prescription to check their compliance and to explore reasons for non-compliance.
Main analyses of data were the prevalence of visual impairment and its causes, risk factors for myopia, and compliance with spectacles at 3 and at 6 months.
Results
Prevalence of impaired visual acuity and causes 6,904 students were screened by the eye team. 2.9% of students had uncorrected poor VA, 2.3% had poor presenting VA and 0.6% still had poor VA with best correction. The main cause of visual impairment was significant refractive error (84%).
The prevalence of uncorrected significant RE in secondary school students in Dar es Salaam was low at 1.8%. Even assuming that all students with unconfirmed poor presenting screening eyesight (0.8%) had uncorrected significant RE which is unlikely the maximum prevalence would be estimated at 2.6%.
Compliance with spectacles
Students who had actually purchased their spectacles were up to twice as likely to wear them at 3 and at 6 months as students who had received free spectacles, but only a small proportion had purchased them (3 months: 30%; 6 months: 45%). Only 46% of students who had received free spectacles wore them or had them at school at 3 months and 53% at 6 months. Significant independent predictors of students wearing or having their spectacles at school 3 to 6 months after prescription or provision of free spectacles were:
Having to purchase spectacles (less likely, OR=0.07 to 0.42)
Bilateral good presenting vision, such as mild refractive errors and undercorrected significant errors (less likely than unilateral visual impairment) and unilateral visual impairment (less likely than bilateral visual impairment; OR=0.47 for each step)
Myopia compared to astigmatism and hyperopia, both severe enough to impair distance vision (more likely, OR= 68 -infinity) The majority of students who were going to purchase spectacles seemed to purchase them soon after prescription.
Risk factors for myopia Female sex, non-African ethnicity and a professional mother were independent significant risk factors for myopia in this population. These findings are similar to risk factors for myopia found in other populations.
Conclusions/ Recommendation
Significant refractive errors were the most common cause of avoidable visual impairment in Tanzanian secondary school students in Dar es Salaam. However, the prevalence of uncorrected bilateral and unilateral significant refractive errors in Form 1 students was low (less than 3%) which makes the value of screening for RE in this population questionable. Screening seems even less justified if one considers that only about 46% of students who had been provided with free spectacles wore spectacles or had them at school three months later. If students were asked to purchase spectacles, this proportion was even lower at 26%.
Similar studies in different cultural settings are needed to explore the compliance with and reasons of non-compliance with spectacles in children, as poor compliance makes the value of any screening programme questionable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Under- and Uncorrected Significant Refractive Errors
Keywords
significant refractive errors, children, spectacles, Africa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
spectacles
Primary Outcome Measure Information:
Title
The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of un- or undercorrected significant refractive error
form 1 student in participating secondary schools
Exclusion Criteria:
presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Gilbert, Reader
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Secondary Schools
City
Dar es Salaam
Country
Tanzania
12. IPD Sharing Statement
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Effectiveness of Alternative Approaches to Providing Spectacles in Tanzanian Secondary School Students
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