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

Farwaniya Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Corneal Perforation; Exposure Keratitis; Infectious Keratitis

Treatments: Combination Product: OmniLenz®

Study type: Interventional

Funder types: Other

Identifiers

NCT06539663

2024-632-4385

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Treatment of Corneal Perforation

Experimental group

Description:

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.

Treatment:

Combination Product: OmniLenz®