Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

March 30, 2023 updated by: Prof. Mohammed Iqbal, Sohag University

Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

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

  • Egypt
      • Sohag, Egypt, 82425
        • Faculty of medicine

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric patient less than 18 years old
  • keratoconus stage I-III ABCD keratoconus grading system

Exclusion Criteria:

  • age more than 18 years
  • previous eye surgery
  • current eye infection or pathology

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard CXL
Patients treated according to Dresden Protocol with epithelium-off CXL.
Procedure: Standard CXL
Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.
Experimental: Accelerated CXL
Patients treated according to accelerated Protocol with epithelium-off CXL.
Procedure: Accelerated CXL
Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.
Experimental: Transepithelial CXL
Patients treated according to transepithelial Protocol with epithelium-on CXL.
Procedure: Transepithelial CXL
Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected distance visual acuity
Time Frame: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
36 months
Corrected distance visual acuity
Time Frame: 36 months
measured in logarithm of minimal angle of resolution (logMAR)
36 months
Sphere
Time Frame: 36 months
measured in diopters (D)
36 months
Cylinder
Time Frame: 36 months
measured in diopters (D)
36 months
Keratometry (Kmax)
Time Frame: 36 months
measured in diopters (D)
36 months

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mohammed Iqbal, MD, PhD, Sohag University Hospital

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)

June 1, 2018

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-4/2018

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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