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Completed

NCT Number: NCT03670303

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.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Islamabad Model School for Boys G-11/2, Islamabad, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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

Exclusion criteria

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

Treatment and study plan

Educational intervention

Behavioral

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

Primary outcomes

  1. Purchase of Spectacles

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

    Observed wear or possession of purchased glasses.

Secondary outcomes

  1. Wear of spectacles

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

    Observed wear of spectacles

Sponsors and collaborators

Lead sponsor

Isra University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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