Prevalence of Refractive Errors in Primary School Children

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05781997
• Collaborator: (none)
• Enrollment: 500
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Diagnostic Test: cycloplegic refraction

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

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence of Refractive Errors in Primary School Children in The New Valley
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Outcome Measures

Primary Outcome Measures

1. prevalence of refractive error in primary school children [baseline]

   determine the prevalence of refractive error in primary school children aged 6-12 in New Valley, Egypt .

Secondary Outcome Measures

1. Degree of Visual aquity improvement of children. [Baseline]

   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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

• Study Director: Omar Mo Ali, Professor, supervisor
• Study Director: Ahmed Mh fahmy, AssProfessor, supervisor
• Study Director: Mohammed An Sayed, Lecturer, supervisor
• Principal Investigator: Doaa An Mohammed, Resident, Investigator

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Distribution of refractive error among chinese primary school children in a rural area in Pahang, Malaysia

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.
• 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.
• 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.

• Responsible Party: Doaa Anwar Mohamed Said, Mut ,The New Valley , Egypt, Assiut University
• ClinicalTrials.gov Identifier: NCT05781997
• Other Study ID Numbers: refractive errors
• First Posted: Mar 23, 2023
• Last Update Posted: Mar 23, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Refractive Errors; Mydriatics

Study Results

No Results Posted as of Mar 23, 2023