Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus

Not Applicable

Completed

• Conditions: Corneal Ectasia
• Interventions: Procedure: Standard CXL; Procedure: Transepithelial CXL; Procedure: Accelerated CXL

• Registration Number: NCT05691335
• Lead Sponsor: Sohag University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-05
• Study First Submitted: 2023-01-07
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CXL	Standard CXL	Patients treated according to Dresden Protocol with epithelium-off CXL.
Transepithelial CXL	Transepithelial CXL	Patients treated according to transepithelial Protocol with epithelium-on CXL.
Accelerated CXL	Accelerated CXL	Patients treated according to accelerated Protocol with epithelium-off CXL.

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity	36 months	measured in logarithm of minimal angle of resolution (logMAR)
Sphere	36 months	measured in diopters (D)
Uncorrected distance visual acuity	36 months	measured in logarithm of minimal angle of resolution (logMAR)
Keratometry (Kmax)	36 months	measured in diopters (D)
Cylinder	36 months	measured in diopters (D)

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Sohag, Egypt