NCT05781997

Brief Summary

The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 5, 2023

Last Update Submit

March 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 .

    baseline

Secondary Outcomes (1)

  • Degree of Visual aquity improvement of children.

    Baseline

Interventions

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.

Eligibility Criteria

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

Primary school children aged 6-12 in New Valley, Egypt not complaining from any diseases .

You may qualify if:

  • 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

You may not qualify if:

  • Retinopathy, Prematurity, history of genetic disease, connective tissue diseases (e.g. Stickler or Marfan syndromes, any ocular diseases, Glaucoma, Cataract, Squint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 17299340BACKGROUND
  • Glascoe 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.

    PMID: 12659386BACKGROUND
  • Friedman 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.

    PMID: 18538407BACKGROUND

Related Links

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Omar Mo Ali, Professor

    supervisor

    STUDY DIRECTOR
  • Ahmed Mh fahmy, AssProfessor

    supervisor

    STUDY DIRECTOR
  • Mohammed An Sayed, Lecturer

    supervisor

    STUDY DIRECTOR
  • Doaa An Mohammed, Resident

    Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa An Mohamed, M.B.B.CH

CONTACT

Doaa An Mohammed, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mut ,The New Valley , Egypt

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 23, 2023

Study Start

May 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03