- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06348368
Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Sohag, Egypt
- Elshimaa A.Mateen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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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
Sponsor
Investigators
- Principal Investigator: Elshimaa A.Mateen, Assistant professor of ophthalmology, Sohag University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-01-29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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