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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06539663

Enrollment

Registered

2024-08-06

Start date

2022-04-10

Completion date

2024-04-10

Last updated

2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Perforation, Exposure Keratitis, Infectious Keratitis

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.

Interventions

COMBINATION_PRODUCTOmniLenz®

OmniLenz® applied for 1 week in all patients after development of corneal perforation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

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

Secondary

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

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026