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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05781997
Other study ID # refractive errors
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date September 2023

Study information

Verified date March 2023
Source Assiut University
Contact Doaa An Mohamed, M.B.B.CH
Phone 01211544543
Email doaa2nwr@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date September 2023
Est. primary completion date August 2023
Accepts healthy volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
cycloplegic refraction
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 .
Baseline
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