Refractive ErrorsNCT05781997
Prevalence of Refractive Errors in Primary School Children
An observational study of Refractive Errors, run by Assiut University.
Trial summary
The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt . Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- cycloplegic refraction
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to Sep 2023
- 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
- Child
Study population: Primary school children aged 6-12 in New Valley, Egypt not complaining from any diseases .
Who may be able to join
- Age: 6 -12-year-old Myopia :- 0.5 D to -10D Hypermetropia: 1 D to 8 D Astigmatism: 0 to 6 D Distance correction: 0.1 logs MAR (20/25 ) or better
Who cannot join
- Retinopathy, Prematurity, history of genetic disease, connective tissue diseases (e.g. Stickler or Marfan syndromes, any ocular diseases, Glaucoma, Cataract, Squint.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Refractive Errors in Primary School Children in The New Valley
The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt .
Read the detailed description
The refractive state of the eye changes as the eye's axial length increases and the cornea and lens flattens. In general, eyes are hyperopic at birth, and become slightly more hyperopic until the age of 7, at this point we see a myopic shift toward Plano until the eyes reach their adult dimensions, usually by about the age of 16.
- Conditions
- Refractive Errors
- Being tested
- cycloplegic refraction
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycloplegic refractionDiagnostic test
Cycloplegic autorefraction will be attempted on all children using a table-mounted autorefractor . Cycloplegia will be achieved with three drops of 1% cyclopentolate administered 5 min apart and autorefractive measurements will be performed 30 min after the instillation of the last drop. Auto refraction readings of three consecutive measurements will be obtained and the average will be computed automatically in each eye. Each child will be reexamined until three measurements fell within 0.50 diopters (D) if any two measurements varied by >0.50D.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of refractive error in primary school children
determine the prevalence of refractive error in primary school children aged 6-12 in New Valley, Egypt .
Measured: baseline
Secondary outcomes (1)
Degree of Visual aquity improvement of children.
We need to measure : 1-Degree of improvement of visual aquity among those children .
2 - Acceptence of the parents and children to wear spectecles among those population .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Anwar Mohamed Said, Assiut University
- Investigators
- Omar Mo Ali, Professor, Study director, supervisorAhmed Mh fahmy, AssProfessor, Study director, supervisorMohammed An Sayed, Lecturer, Study director, supervisorDoaa An Mohammed, Resident, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781997
- Sponsor's protocol ID
- refractive errors
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
PubMed 17299340Glascoe FP. Parents' evaluation of developmental status: how well do parents' concerns identify children with behavioral and emotional problems? Clin Pediatr (Phila). 2003 Mar;42(2):133-8. doi: 10.1177/000992280304200206.
PubMed 12659386Friedman DS, Repka MX, Katz J, Giordano L, Ibironke J, Hawes P, Burkom D, Tielsch JM. Prevalence of decreased visual acuity among preschool-aged children in an American urban population: the Baltimore Pediatric Eye Disease Study, methods, and results. Ophthalmology. 2008 Oct;115(10):1786-95, 1795.e1-4. doi: 10.1016/j.ophtha.2008.04.006. Epub 2008 Jun 5.
PubMed 18538407
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Refractive Errors in Primary School Children in The New Valley
- ClinicalTrials.gov ID
- NCT05781997
- Acronym / sponsor ID
- refractive errors
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Mar 2023 (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.
The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt .
Detailed description
The refractive state of the eye changes as the eye's axial length increases and the cornea and lens flattens. In general, eyes are hyperopic at birth, and become slightly more hyperopic until the age of 7, at this point we see a myopic shift toward Plano until the eyes reach their adult dimensions, usually by about the age of 16.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Primary school children aged 6-12 in New Valley, Egypt not complaining from any diseases .
Key inclusion criteria (1 listed)
- Age: 6 -12-year-old Myopia :- 0.5 D to -10D Hypermetropia: 1 D to 8 D Astigmatism: 0 to 6 D Distance correction: 0.1 logs MAR (20/25 ) or better
Key exclusion criteria (1 listed)
- Retinopathy, Prematurity, history of genetic disease, connective tissue diseases (e.g. Stickler or Marfan syndromes, any ocular diseases, Glaucoma, Cataract, Squint.
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 |
|---|---|---|
| cycloplegic refractionCycloplegic autorefraction will be attempted on all children using a table-mounted autorefractor . Cycloplegia will be achieved with three drops of 1% cyclopentolate administered 5 min apart and autorefractive measurements will be performed 30 min after the instillation of the last drop. Auto refraction readings of three consecutive measurements will be obtained and the average will be computed automatically in each eye. Each child will be reexamined until three measurements fell within 0.50 diopters (D) if any two measurements varied by >0.50D. | Diagnostic test | – |
Primary outcome
prevalence of refractive error in primary school children
Time frame: baseline
determine the prevalence of refractive error in primary school children aged 6-12 in New Valley, Egypt .
1 secondary outcome
Degree of Visual aquity improvement of children.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 17299340Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
- Background: PubMed 12659386Glascoe FP. Parents' evaluation of developmental status: how well do parents' concerns identify children with behavioral and emotional problems? Clin Pediatr (Phila). 2003 Mar;42(2):133-8. doi: 10.1177/000992280304200206.
- Background: PubMed 18538407Friedman DS, Repka MX, Katz J, Giordano L, Ibironke J, Hawes P, Burkom D, Tielsch JM. Prevalence of decreased visual acuity among preschool-aged children in an American urban population: the Baltimore Pediatric Eye Disease Study, methods, and results. Ophthalmology. 2008 Oct;115(10):1786-95, 1795.e1-4. doi: 10.1016/j.ophtha.2008.04.006. Epub 2008 Jun 5.
- Distribution of refractive error among chinese primary school children in a rural area in Pahang, MalaysiaLink provided by the sponsor.
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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.
Omar Mo Ali, Professor study director
supervisor
Ahmed Mh fahmy, AssProfessor study director
supervisor
Mohammed An Sayed, Lecturer study director
supervisor
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Assiut University.
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 1 inclusion and 1 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Doaa An Mohamed, M.B.B.CH (01211544543, doaa2nwr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of refractive error in primary school children (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781997, which also lists 3 linked publications.
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 23 Mar 2023.