Error, RefractiveNCT05366543
Errors of Refraction Among Primary School Children
An observational study of Error, Refractive, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Error, Refractive
- What is being tested?
- Visual acuity measurement
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2022to 31 Dec 2025
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Primary school student less than 12 years with no sensory defects in their eyes
Who may be able to join
- Primary school student less than 12 years.
- No sensory defect in those children.
Who cannot join
- Corneal opacity.
- Abnormal fundus lesion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Minya, Minya Governorate, 61111
Mohamed FK Ibrahiem, MD, 00201064311860, mohamedfka@yahoo.com
About this study
Official title: Errors of Refraction: Prevalence and Compliance of Wearing Correction Among Primary School Children
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.
- Conditions
- Error, Refractive
- Being tested
- Visual acuity measurement
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity improvement
Measurement of visual acuity after wearing of glasses
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 Jan 2022
- Primary completion20 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Error, RefractiveStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366543
- Sponsor's protocol ID
- Paediatric unit
- Status last verified
- Mar 2024
- First submitted
- 5 May 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Errors of Refraction: Prevalence and Compliance of Wearing Correction Among Primary School Children
- ClinicalTrials.gov ID
- NCT05366543
- Acronym / sponsor ID
- Paediatric unit
- Conditions
- Error, Refractive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 May 2022 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Primary school student less than 12 years with no sensory defects in their eyes
Key inclusion criteria (2 listed)
- Primary school student less than 12 years.
- No sensory defect in those children.
Key exclusion criteria (2 listed)
- Corneal opacity.
- Abnormal fundus lesion.
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 |
|---|---|---|
| Visual acuity measurementVisual acuity will be measured using autorefractometer after cycloplegic eye drops 3 times and glasses will be prescribed for those who are needed. | Diagnostic test | – |
Primary outcome
Visual acuity improvement
Time frame: 3 months
Measurement of visual acuity after wearing of glasses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Error, Refractive, run by Minia University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity improvement (time frame: 3 months). 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 15 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.