NCT07080983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

July 15, 2025

Last Update Submit

July 15, 2025

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (4)

  • keratometry (Kmax)

    Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.

    Baseline

  • keratometry (Kmax)

    Kmax (Maximum Keratometry) is the steepest point of curvature on the cornea, and it is a key parameter in diagnosing and monitoring keratoconus.

    After 12 months

  • BCVA

    Measurment of the visual acuity

    Baseline

  • BCVA

    Measurment of the visual acuity

    After 12 months

Study Arms (1)

Cross-linking

OTHER
Procedure: Crosslinking

Interventions

CrosslinkingPROCEDURE

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.

Cross-linking

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

Al-Azhar university

Damietta, Egypt

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princibal Investigator

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 23, 2025

Study Start

April 2, 2024

Primary Completion

May 2, 2025

Study Completion

July 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

EG(2)