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Clinical Trials/NCT06539663
NCT06539663CompletedPhase 2

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

Farwaniya Hospital2 sites in 1 country5 target enrollmentStarted: April 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
5
Locations
2
Primary Endpoint
Size of corneal perforation

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Size of corneal perforation

Time Frame: one week

Size of corneal perforation will be measured in mm using slit lamp examination

Secondary Outcomes

  • size of epithelial defect(one week)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Nancy Lotfy, MD

Associate Professor of Ophthalmology

Cairo University

Study Sites (2)

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