Cross-linking as Treatment in Infectious Keratitis

Not Applicable

Completed

• Conditions: Infectious Keratitis
• Interventions: Procedure: PACK-CXL

• Registration Number: NCT04383431
• Lead Sponsor: Sohag University

Brief Summary

To compare between SCXL and ACXL for treatment of infectious keratitis

Detailed Description

Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode (Group A). Accelerated CXL 11 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode (Group B).

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2020-06-02
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-15
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Fungal infectious keratitis
• bacterial infectious keratitis
• Must be not responding to medication

Exclusion Criteria

• Viral keratitis
• Pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CXL	PACK-CXL	Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.
Accelerated CXL	PACK-CXL	Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.

Primary Outcome Measures

Name	Time	Method
Corneal healing	3 months	Reepithelization of corneal ulcer which is measured in mm by slitlamp examination
Corneal edema	3 months	measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Sohag, Egypt