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CompletedNCT03670303Updated Sep 5, 2021

Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan

An interventional study of Educational intervention in Refractive Errors and Visual Impairment, sponsored by Isra University. Completed at 8 sites in Pakistan. Open to participants aged 11 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Isra University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
11 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Refractive Errors
  • Visual Impairment
03

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:-

1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.

Exclusion Criteria:

  1. Children from 10th grade which is the final grade of secondary schools.
  2. Children with eye disorders other than refractive error.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Intervention group

    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.

    Behavioral: Educational intervention

  • No intervention
    Control group

    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.

Interventions

  • BehavioralEducational intervention

    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: 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

05

What researchers measure

Primary outcomes

  1. Purchase of Spectacles

    Observed wear or possession of purchased glasses.

    Time frame: 3 months follow-up after baseline visit.

Secondary outcomes

  1. Wear of spectacles

    Observed wear of spectacles

    Time frame: 6months and one year follow-up after baseline visit.

06

Study locations

8 sites
  • Islamabad Model School for Boys G-11/2
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Boys I-10/2
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Boys I-8/4
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Boys I-9/4
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Girls 1-10/4
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Girls F-6/1
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Girls F-7/2
    Islamabad, 46000, Pakistan
  • Islamabad Model School for Girls G-7/1
    Islamabad, 46000, Pakistan
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03670303
Lead sponsor
Isra University
Responsible party
Nusrat Nasim (PHD Scholar, Isra University) — Principal investigator
First posted
Sep 13, 2018
Start date
Sep 27, 2018
Primary completion
Mar 8, 2019
Completion
Feb 12, 2020
Last update
Sep 5, 2021

Study contacts

Shaista Habibullah, PhD
study director · Director (Tech)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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