Efficacy of Corneal Cross-Linking (CXL) in the Treatment of Pediatric Keratoconus

NCT ID: NCT07080983

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2025-07-01

Brief Summary

This prospective interventional study investigates the efficacy of corneal cross-linking (CXL) in managing progressive keratoconus in pediatric patients. The procedure involved standard epithelium-off CXL, and patients were followed to assess outcomes such as visual acuity, keratometric stability, and corneal thickness.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cross-linking

Group Type: OTHER

Crosslinking

Intervention Type: PROCEDURE

Corneal Cross-Linking (CXL) is a minimally invasive procedure used to strengthen the cornea by increasing the chemical bonds between collagen fibers. It is primarily used to treat keratoconus and corneal ectasia, conditions where the cornea becomes progressively thinner and weaker.

Interventions

Crosslinking

Corneal Cross-Linking (CXL) is a minimally invasive procedure used to strengthen the cornea by increasing the chemical bonds between collagen fibers. It is primarily used to treat keratoconus and corneal ectasia, conditions where the cornea becomes progressively thinner and weaker.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 8 and 18 years
• Clinical and topographic diagnosis of keratoconus based on the Belin/Ambrosio Enhanced Ectasia Display
• Evidence of progression within the past 6-12 months (e.g., an increase in maximum keratometry (Kmax) by ≥1.0 diopter, a decrease in minimal corneal thickness by ≥10 µm, or deterioration in visual acuity not attributable to other causes

Exclusion Criteria

• Corneal scarring or opacities.
• Active ocular infection or inflammation.
• Prior ocular surgery or trauma.
• Autoimmune or connective tissue disorders.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Tharwat

Princibal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ehab tharwat

Damietta, New Damietta, Egypt

Al-Azhar university

Damietta, , Egypt

Countries

Egypt

Other Identifiers

Pediatric Keratoconus

Identifier Type: -

Identifier Source: org_study_id