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NCT04383431 Clinical Trial

Cross-linking as Treatment in Infectious Keratitis

Infectious Keratitis Clinical Trial

Official title:
Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04383431
Other study ID # 4-9/12/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2020
Est. completion date January 15, 2023

Study information
Verified date January 2023
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare between SCXL and ACXL for treatment of infectious keratitis

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).

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date January 15, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Fungal infectious keratitis - bacterial infectious keratitis - Must be not responding to medication Exclusion Criteria: - Viral keratitis - Pregnancy and lactation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PACK-CXL
Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.

Locations
Country Name City State
Egypt Faculty of medicine Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal healing Reepithelization of corneal ulcer which is measured in mm by slitlamp examination 3 months
Primary Corneal edema measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography 3 months
See also
  Status Clinical Trial Phase
Completed NCT04030403 - Investigation of the Microbiome of the Cornea in Microbial Keratitis
Completed NCT04213313 - Association Between SNP of SP-D and Susceptibility and Prognosis of Infectious Keratitis
Recruiting NCT02570321 - Cross-linking for Corneal Ulcers Treatment Trial Phase 4
Terminated NCT00912509 - Cross Linking for Treatment of Corneal Infection N/A
Completed NCT01831206 - Collagen Cross-linking in Infectious Keratitis Trial Phase 2
Recruiting NCT05888987 - Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection
Not yet recruiting NCT03801590 - Crosslinking in Infectious Keratitis N/A
Recruiting NCT06364878 - Non-invasive Diagnostics of Microbial Keratitis
Completed NCT01739673 - Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis N/A
Completed NCT02819232 - Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs N/A