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Completed

NCT Number: NCT06539663

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

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.

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Key information

Conditions

Corneal Perforation Corneal Diseases Corneal Injuries Craniocerebral Trauma Exposure Keratitis Eye Diseases Eye Injuries Facial Injuries Infectious Keratitis Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Farwaniya Hospital

Kuwait City, 81004, PO Box 13372, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OmniLenz®

Combination Product

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

Primary outcomes

  1. Size of corneal perforation

    Time frame: one week

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

Secondary outcomes

  1. size of epithelial defect

    Time frame: one week

    Size of epithelial defect will be measured in mm using slit lamp examination

Sponsors and collaborators

Lead sponsor

Farwaniya Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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