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.
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
- Conditions the study is for
- Under- and Uncorrected Significant Refractive Errors
- 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
- Are there results?
- None posted in the registry
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.
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
- 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.
- 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.
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.
- First posted7 Nov 2005 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Under- and Uncorrected Significant Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- British Council for Prevention of Blindness, Tanzanian Society for the Blind
- Investigators
- Clare Gilbert, Reader, Principal investigator, London School of Hygiene and Tropical Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Alternative Approaches to Providing Spectacles in Secondary School Students in Dar Es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT00249275
- Acronym / sponsor ID
- ITCRBY79
- Keywords
- significant refractive errors, children, spectacles, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- British Council for Prevention of Blindness, Tanzanian Society for the Blind
- Study start
- Jan 2004
- Study completion
- Aug 2004
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of un- or undercorrected significant refractive error
- form 1 student in participating secondary schools
Key exclusion criteria (1 listed)
- presenting VA of 6/12 or better in both eyes and no hyperopia of +2D or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spectacles | Device | – |
Primary outcome
The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2005.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Gilbert, Reader principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of students who had been given/prescribed spectacles who were wearing spectacles 3 and 6 months later. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2005.