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

April 6, 2024 updated by: Elshimaa A.Mateen, Sohag University
Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sohag, Egypt
        • Elshimaa A.Mateen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Children live in upper Egypt with high cylinder and no corneal scar.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (control group)
Children with normal Pentacam and with no refractive errors
Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children
Group 2 (children with high cylinder and no corneal topographic abnormalities)
Children with high cylinder without corneal topographic ectasia.
Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children
Group 3 (Children with high cylinder and corneal ectatic changes).
Children with high cylinder and corneal ectatic changes
Pentacam to detect corneal topographic changes. Auto-refractometry to assess refraction condition of the children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values anterior and posterior corneal elevation values by pentacam.
Time Frame: one year
Corneal topgraphic changes in children with high cylinder in upper Egypt
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elshimaa A.Mateen, Assistant professor of ophthalmology, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 30, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-23-01-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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