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NCT06348368 Clinical Trial

Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder

Corneal Ectasia Clinical Trial

Official title:
Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06348368
Other study ID # Soh-Med-23-01-29
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date February 1, 2024

Study information
Verified date April 2024
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study

Description:

Astigmatism is defined as, a refractive condition in which refractive light fails to form a focus on the retina, it accounts for about 13% of refractive errors. It is frequent and correctable cause of visual impairment in children whether associated with spherical errors or not. Astigmatism, is the refractive error of the highest clinical importance, being associated with reduced visual acuity with subsequent development of refractive amblyopia. High cylinder in children belong to areas of hot and dry climates, makes exclusion of keratoconus is mandatory. Population in the African continent, the Mediterranean countries, Central and South America, and the Indian subcontinent usually have the habit of eye rubbing because of bothering symptoms of dryness, itching, atopy, allergy and vernal keratoconjunctivitis, which is the severe form of allergic conjunctivitis. Eye rubbing causes thinning of keratocyte and increases the prevalence of keratoconus. Keratoconus in children (diagnosed before the age of eighteenth) is less common but more aggressive than that of the adults, due to the dynamic nature of the young cornea. Few studies in the literature reported the prevalence and incidence of keratoconus in children. Pentacam is an advanced instrument with a rotating Scheimpflug camera for scanning the anterior and posterior corneal surfaces. Its measurements of the corneal thickness and posterior elevation have been proved to be of high reproducibility and repeatability.

Recruitment information / eligibility
Status Completed
Enrollment 4000
Est. completion date February 1, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria: - Upper Egypt children with high cylinder(refractive errorr). Exclusion Criteria: - Children below age of 7 years old (uncooperative), patients above age of 18 years old.Patients with corneal scars

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pentacam and autorefractometry
Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children

Locations
Country Name City State
Egypt Elshimaa A.Mateen Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Values anterior and posterior corneal elevation values by pentacam. Corneal topgraphic changes in children with high cylinder in upper Egypt one year
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