NCT05366543

Brief Summary

This study will include primary school children to evalute their refraction and follow those who will wear glasses to detect their compliance. Visual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed. Follow up of the students to detect their compliance of wearing correction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

May 5, 2022

Last Update Submit

March 12, 2024

Conditions

Error, Refractive

Outcome Measures

Primary Outcomes (1)

  • Visual acuity improvement

    Measurement of visual acuity after wearing of glasses

    3 months

Interventions

Visual acuity measurementDIAGNOSTIC_TEST

Visual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary school student less than 12 years with no sensory defects in their eyes

You may qualify if:

  • Primary school student less than 12 years.
  • No sensory defect in those children.

You may not qualify if:

  • Corneal opacity.
  • Abnormal fundus lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 9, 2022

Study Start

January 3, 2022

Primary Completion

December 20, 2025

Study Completion

December 31, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

EG(1)