CClinicalTrials.gg
CompletedNCT00249275Updated Nov 7, 2005

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

An interventional study of spectacles in Under- and Uncorrected Significant Refractive Errors, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Tanzania. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2005-11-07.

Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
0 Years and older
Sex
All
01

Study 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 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.
  3. 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.
02

Conditions studied

  • Under- and Uncorrected Significant Refractive Errors

Browse trials for

Keywords

  • significant refractive errors
  • children
  • spectacles
  • Africa
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 250 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
250 participants

Interventions

  • Devicespectacles
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Secondary Schools
    Dar es Salaam, Tanzania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00249275
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
British Council for Prevention of Blindness, Tanzanian Society for the Blind
First posted
Nov 7, 2005
Start date
Jan 2004
Completion
Aug 2004
Last update
Nov 7, 2005

Study contacts

Clare Gilbert, Reader
principal investigator · London School of Hygiene and Tropical Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2004. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion