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Cross-linking as Treatment in Infectious Keratitis

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04383431
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
42
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare between SCXL and ACXL for treatment of infectious keratitis

Condition or Disease Intervention/Treatment Phase
  • Procedure: PACK-CXL
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Standard Cross-linking Versus Accelerated Photoactivated Chromophore Cross-linking (PACK-CXL) for Treatment of Infectious Keratitis: A Comparative Study
Actual Study Start Date :
Jun 2, 2020
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard CXL

Standard epithelium-off CXL, 30 minutes soaking time with riboflavin, 30 minutes UVA corneal irradiation continuous mode.

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

Accelerated epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation continuous mode.

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

Outcome Measures

Primary Outcome Measures

  1. Corneal healing [3 months]

    Reepithelization of corneal ulcer which is measured in mm by slitlamp examination

  2. Corneal edema [3 months]

    measurement of corneal edema by measurement of the corneal thickness in um by Optical Coherent Tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Fungal infectious keratitis

  • bacterial infectious keratitis

  • Must be not responding to medication

Exclusion Criteria:

  • Viral keratitis

  • Pregnancy and lactation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Sohag Egypt 82425

Sponsors and Collaborators

  • Sohag University

Investigators

  • Principal Investigator: Mohammed Iqbal, MD. PhP, 00201068559840

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Mohammed Iqbal, Assistant Professor of Ophthalmology, Sohag University
ClinicalTrials.gov Identifier:
NCT04383431
Other Study ID Numbers:
  • 4-9/12/2018
First Posted:
May 12, 2020
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Communicable Diseases
Infections
Keratitis

Study Results

No Results Posted as of Jan 3, 2022