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Under- and Uncorrected Significant Refractive ErrorsNCT00249275

Effectiveness of Alternative Approaches to Providing Spectacles in Tanzanian Secondary School Students

A study testing spectacles in people with Under- and Uncorrected Significant Refractive Errors, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 0 years and older
What is being tested?
spectacles
Type of treatment
Medical device
How many people
250 participants
Where
1 siteTanzania
Study dates
Jan 2004to Aug 2004
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • clinical diagnosis of un- or undercorrected significant refractive error
  • form 1 student in participating secondary schools

Who cannot join

  • presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher

Trial locations and contacts

1 site in 1 country.

Tanzania1 site
  • Secondary Schools

    Dar es Salaam, Dar es Salaam Region

Other trials in Tanzania

About this study

Official title: Evaluation of the Effectiveness of Alternative Approaches to Providing Spectacles in Secondary School Students in Dar Es Salaam, Tanzania

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.

Read the 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

  1. To estimate the prevalence and type of significant refractive errors in secondary school children in Tanzania, and to determine the unmet need for spectacles
  2. 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
  3. 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

  1. 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%.
  2. 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.
  1. 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

  1. 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%.
  2. 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.
Being tested
spectacles
Keywords
significant refractive errors, children, spectacles, Africa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spectaclesDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2005 (estimated)
  2. Study startJan 2004
  3. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00249275
Sponsor's protocol ID
ITCRBY79
Status last verified
Jan 2004
First submitted
3 Nov 2005
Last updated
7 Nov 2005
Results posted
No

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