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

Phase 2

Completed

• Conditions: Infectious Keratitis; Corneal Perforation; Exposure Keratitis

• Registration Number: NCT06539663
• Lead Sponsor: Farwaniya Hospital

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 Timeline

• Study Start: 2022-04-10
• Primary Completion: 2024-02-10
• Study Completion: 2024-04-10
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Size of corneal perforation	one week	Size of corneal perforation will be measured in mm using slit lamp examination

Secondary Outcome Measures

Name	Time	Method
size of epithelial defect	one week	Size of epithelial defect will be measured in mm using slit lamp examination

Trial Locations

Locations (1)

Farwaniya Hospital; 🇰🇼 Kuwait, Kuwait