The Role of OmniLenz® in the Treatment of Small Corneal Perforations Secondary to Exposure Keratitis in ICU Patients

August 1, 2024 updated by: Nancy Lotfy, MD, Farwaniya Hospital

Case series of 5 ICU patients in Farwaniya Hospital who developed exposure keratitis and a subsequent small corneal perforation between April 2022 and April 2024.

The investigators highlight the non-surgical role of OmniLenz® in the treatment of small corneal perforations secondary to exposure keratitis. The inclusion criteria were corneal perforation less than 1mm in size, positive culture & sensitivity results and showing initial improvement on topical antibiotic eye drops.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary outcome measures were healing of the corneal perforation, a negative Seidel test and reformation of the anterior chamber.

Secondary outcome measures were improvement of all three of ciliary injection, state of epithelial defect, and corneal infiltration.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Kuwait
      • Kuwait, Kuwait, 81004, PO Box 13372
        • Farwaniya Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion/Exclusion Criteria:

  • Patients with small corneal perforations measuring < 1 mm in diameter. Those with larger perforations (>1mm) were excluded.
  • Patients with conclusive results of keratitis (confirmed via culture and sensitivity scraping) AND showing improved keratitis following antibiotic treatment. Those with no confirmed keratitis through C&S or with inconclusive scraping results were excluded.
  • No age or gender restrictions were applied.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment of Corneal Perforation

All patients were prescribed Fortified Vancomycin (50mg %) and Fortified Fortum (50mg %) antibiotic eye drops for initial exposure keratitis with corneal infiltration. Then treatment was modified according to culture and sensitivity results.

Subsequent corneal perforation developed for which OmniLenz® was applied in all patients for 1 week.
Combination product: OmniLenz®
OmniLenz® applied for 1 week in all patients after development of corneal perforation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of corneal perforation
Time Frame: one week
Size of corneal perforation will be measured in mm using slit lamp examination
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of epithelial defect
Time Frame: one week
Size of epithelial defect will be measured in mm using slit lamp examination
one week

Collaborators and Investigators

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

Sponsor

Farwaniya Hospital

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 (Actual)

April 10, 2022

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

April 10, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-632-4385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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