Refractive ErrorsNCT03670303
Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
A study testing Educational intervention in people with Refractive Errors and Visual Impairment, run by Isra University at 8 sites in Pakistan.
Trial summary
This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for… Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Refractive Errors, Visual Impairment
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesPakistan
- Study dates
- 27 Sep 2018to 12 Feb 2020
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.
Who cannot join
- Children from 10th grade which is the final grade of secondary schools.
- Children with eye disorders other than refractive error.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Pakistan8 sites
Islamabad Model School for Boys G-11/2
Islamabad, 46000
Islamabad Model School for Boys I-10/2
Islamabad, 46000
Islamabad Model School for Boys I-8/4
Islamabad, 46000
Islamabad Model School for Boys I-9/4
Islamabad, 46000
Islamabad Model School for Girls 1-10/4
Islamabad, 46000
Islamabad Model School for Girls F-6/1
Islamabad, 46000
Islamabad Model School for Girls F-7/2
Islamabad, 46000
Islamabad Model School for Girls G-7/1
Islamabad, 46000
About this study
Official title: Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for non-compliance towards spectacle use will be explored and educational intervention will be planned considering these reasons. Educational intervention will increase awareness about the importance of spectacles use and reduce the barriers towards spectacle use.Reducing barriers will increase compliance towards spectacles use which will ultimately prevent the avoidable visual impairment.
Read the detailed description
Aim of this research is to improve school performance and quality of life of children with refractive errors. Planned research will be carried out in eight (4 girls and 4 boys) Public Sector Secondary Schools of Islamabad and vision of students will be tested with standard snellen chart to recruit 120 boys and 120 girls with refractive errors. Students having vision ≤ 6/12 will receive auto refraction and prescription of spectacles will be given after subjective refraction. primary outcome of purchase of glasses will be asessed at three months after prescribing. Follow up after six months of prescribing spectacles will find out compliance towards spectacles. Non-compliant students will be given a questionnaire to provide the reasons for non-compliance towards spectacles. Focus Group Discussions (FGDs) will be conducted with non-compliant students, their teachers and parents to explore reasons of non compliance.
On the basis of information obtained from FGDs an educational intervention will be planned for students, their parents and teahers to explain importance of spectacles. Through stratified randomization schools will be assigned to intervention and control groups. Four schools including two girls and two boys schools will be assigned to intervention group and four schools (two girls and two boys) will be assigned to control group. Educational intervention will be given to intervention group. Six months after the intervention compliance to spectacle wear will be assessed than pre and post intervention compliance in intervention group and between two groups will be compared to assess effectiveness of intervention.
- Conditions
- Refractive Errors, Visual Impairment
- Being tested
- Educational intervention
- Medical subject headings
- Refractive Errors, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
Educational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes:
- Lectures on importance of spectacles use including visual materials such as pictures and videos.
- An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA.
- Posters
- Brochures
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group will include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance will be assessed at 6 months follow-up after baseline assessment than educational intervention will be given. Six months after intervention compliance will be assessed again. Receives: Behavioral: Educational intervention |
| Control group | No intervention | This group will also include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance towards spectacle use will be assessed at 6 months after baseline assessment. No intervention will be given in this group. Compliance will be assessed again at the same time when assessed in intervention group 6 months after the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase of Spectacles
Observed wear or possession of purchased glasses.
Measured: 3 months follow-up after baseline visit.
Secondary outcomes (1)
Wear of spectacles
Observed wear of spectacles
Measured: 6months and one year follow-up after baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start27 Sep 2018
- Primary completion8 Mar 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will involve two groups intervention group and no intervention (control) group. each group will include two boys and two girls schools. Educational intervention will be given to two boys and two girls schools. Remaining two boys and two girls schools will not receive educational intervention. Simultaneous follow-ups will be carried out in two groups to assess compliance towards spectacles use.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nusrat Nasim, Isra University
- Investigators
- Shaista Habibullah, PhD, Study director, Director (Tech)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670303
- Sponsor's protocol ID
- IIRS-IUISB/1602-PHD-005
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
- ClinicalTrials.gov ID
- NCT03670303
- Acronym / sponsor ID
- IIRS-IUISB/1602-PHD-005
- Conditions
- Refractive Errors, Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for non-compliance towards spectacle use will be explored and educational intervention will be planned considering these reasons. Educational intervention will increase awareness about the importance of spectacles use and reduce the barriers towards spectacle use.Reducing barriers will increase compliance towards spectacles use which will ultimately prevent the avoidable visual impairment.
Detailed description
Aim of this research is to improve school performance and quality of life of children with refractive errors. Planned research will be carried out in eight (4 girls and 4 boys) Public Sector Secondary Schools of Islamabad and vision of students will be tested with standard snellen chart to recruit 120 boys and 120 girls with refractive errors. Students having vision ≤ 6/12 will receive auto refraction and prescription of spectacles will be given after subjective refraction. primary outcome of purchase of glasses will be asessed at three months after prescribing. Follow up after six months of prescribing spectacles will find out compliance towards spectacles. Non-compliant students will be given a questionnaire to provide the reasons for non-compliance towards spectacles. Focus Group Discussions (FGDs) will be conducted with non-compliant students, their teachers and parents to explore reasons of non compliance.
On the basis of information obtained from FGDs an educational intervention will be planned for students, their parents and teahers to explain importance of spectacles. Through stratified randomization schools will be assigned to intervention and control groups. Four schools including two girls and two boys schools will be assigned to intervention group and four schools (two girls and two boys) will be assigned to control group. Educational intervention will be given to intervention group. Six months after the intervention compliance to spectacle wear will be assessed than pre and post intervention compliance in intervention group and between two groups will be compared to assess effectiveness of intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study will involve two groups intervention group and no intervention (control) group. each group will include two boys and two girls schools. Educational intervention will be given to two boys and two girls schools. Remaining two boys and two girls schools will not receive educational intervention. Simultaneous follow-ups will be carried out in two groups to assess compliance towards spectacles use.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Educational interventionThis group will include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance will be assessed at 6 months follow-up after baseline assessment than educational intervention will be given. Six months after intervention compliance will be assessed again. |
| Control group | No intervention | –This group will also include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance towards spectacle use will be assessed at 6 months after baseline assessment. No intervention will be given in this group. Compliance will be assessed again at the same time when assessed in intervention group 6 months after the intervention. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.
Key exclusion criteria (2 listed)
- Children from 10th grade which is the final grade of secondary schools.
- Children with eye disorders other than refractive error.
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 |
|---|---|---|
| Educational interventionEducational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes: 1. Lectures on importance of spectacles use including visual materials such as pictures and videos. 2. An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA. 3. Posters 4. Brochures | Behavioural | Intervention group |
Primary outcome
Purchase of Spectacles
Time frame: 3 months follow-up after baseline visit.
Observed wear or possession of purchased glasses.
1 secondary outcome
Wear of spectacles
Time frame: 6months and one year follow-up after baseline visit.
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 5 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
Shaista Habibullah, PhD study director
Director (Tech)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Refractive Errors and Visual Impairment, run by Isra University at 8 sites in Pakistan.
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 1 inclusion and 2 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Pakistan. 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?
Purchase of Spectacles (time frame: 3 months follow-up after baseline visit.). 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 5 Sep 2021.