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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670303
• Other study ID #: IIRS-IUISB/1602-PHD-005
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: February 12, 2020

Study information

• Verified date: September 2021
• Source: Isra University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 12, 2020
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Errors
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• Educational 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: 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

Locations

Country	Name	City	State
Pakistan	Islamabad Model School for Boys G-11/2	Islamabad
Pakistan	Islamabad Model School for Boys I-10/2	Islamabad
Pakistan	Islamabad Model School for Boys I-8/4	Islamabad
Pakistan	Islamabad Model School for Boys I-9/4	Islamabad
Pakistan	Islamabad Model School for Girls 1-10/4	Islamabad
Pakistan	Islamabad Model School for Girls F-6/1	Islamabad
Pakistan	Islamabad Model School for Girls F-7/2	Islamabad
Pakistan	Islamabad Model School for Girls G-7/1	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Purchase of Spectacles	Observed wear or possession of purchased glasses.	3 months follow-up after baseline visit.
Secondary	Wear of spectacles	Observed wear of spectacles	6months and one year follow-up after baseline visit.