Pack Cross Linking for Infectious Keratitis

May 29, 2023 updated by: Mariam Abdelmawgoud Mohamed, Sohag University

Analysis of the Outcomes of Photoactivated Chromophore for Keratitis Cross _linking for Treatment of Infectious Keratitis

The primary aim of this study is to investigate the efficiency of PACK_ CXL in treatment of infectious keratitis and analyze postoperative outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mohamed i hafez, professor
  • Phone Number: 01068559840

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital
        • Contact:
          • Magdy M Ameen, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT))

Exclusion Criteria:

  • age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness < 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: groupA (control group)
will include 20 eyes of 20 patients with infectious keratitis who will receive antimicrobial therapy.
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
Active Comparator: group B
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated cross-linking Protocol-1 (9 mW/cm2 for 10 minutes to achieve 5.4 J/cm2) followed by antimicrobial therapy
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
Drug: Riboflavin
topical application of riboflavin followed by cross linking
Device: pack cross linking
TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS
Active Comparator: group C
will include 20 eyes of 20 patients with infectious keratitis who will undergo PACK accelerated crosslinking Protocol-2 (18 mW/cm2 for 7 minutes to achieve 7.2 J/cm2) followed by antimicrobial therapy
Drug: Antibotice.g vigamox ED Antifungal e.g Dflucan
topical application of antimicropial therapy
Drug: Riboflavin
topical application of riboflavin followed by cross linking
Device: pack cross linking
TOPICAL application of cross linking after application of Riboflavin TO TREAT INFECTIOUS KERATITIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal THICKNESS
Time Frame: within 60 days
decrease corneal THICKNESS USING ANTERIOR SEGMENT OPTICAL COHERENT TOPOGRAPHY
within 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pack cross linking

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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