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Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Primary Purpose

Corneal Ectasia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Standard CXL

Accelerated CXL

Transepithelial CXL

About this trial

This is an interventional treatment trial for Corneal Ectasia

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Arm Label

Standard CXL

Accelerated CXL

Transepithelial CXL

Arm Description

Patients treated according to Dresden Protocol with epithelium-off CXL.

Patients treated according to accelerated Protocol with epithelium-off CXL.

Patients treated according to transepithelial Protocol with epithelium-on CXL.

Outcomes

Primary Outcome Measures

Uncorrected distance visual acuity

measured in logarithm of minimal angle of resolution (logMAR)

Corrected distance visual acuity

measured in logarithm of minimal angle of resolution (logMAR)

Sphere

measured in diopters (D)

Cylinder

measured in diopters (D)

Keratometry (Kmax)

measured in diopters (D)

Secondary Outcome Measures

Full Information

NCT ID

NCT05691335

First Posted

January 7, 2023

Last Updated

March 30, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05691335

Brief Title

Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

January 1, 2023 (Actual)

Study Completion Date

January 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Ectasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard CXL

Arm Type

Other

Arm Description

Patients treated according to Dresden Protocol with epithelium-off CXL.

Arm Title

Accelerated CXL

Arm Type

Experimental

Arm Description

Patients treated according to accelerated Protocol with epithelium-off CXL.

Arm Title

Transepithelial CXL

Arm Type

Experimental

Arm Description

Patients treated according to transepithelial Protocol with epithelium-on CXL.

Intervention Type

Procedure

Intervention Name(s)

Standard CXL

Intervention Description

Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.

Intervention Type

Procedure

Intervention Name(s)

Accelerated CXL

Intervention Description

Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

Intervention Type

Procedure

Intervention Name(s)

Transepithelial CXL

Intervention Description

Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.

Primary Outcome Measure Information:

Title

Uncorrected distance visual acuity

Description

measured in logarithm of minimal angle of resolution (logMAR)

Time Frame

36 months

Title

Corrected distance visual acuity

Description

measured in logarithm of minimal angle of resolution (logMAR)

Time Frame

36 months

Title

Sphere

Description

measured in diopters (D)

Time Frame

36 months

Title

Cylinder

Description

measured in diopters (D)

Time Frame

36 months

Title

Keratometry (Kmax)

Description

measured in diopters (D)

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed Iqbal, MD, PhD

Organizational Affiliation

Sohag University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of medicine

City

Sohag

ZIP/Postal Code

82425

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

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