Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion

• Status: Withdrawn
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing phase. Current practice guidelines discourage the use of topical anesthetics in treating these patients due to concerns that these medications may prevent proper corneal epithelial healing. These concerns are based primarily on decades old animal based research. However, recent evidence suggests topical anaesthetics are a safe and effective way of managing patient pain in the short term. This study will investigate the effect of topical 0.5% tetracaine on corneal healing and pain management in patients with corneal abrasions in the first 48 hours.

This will be a prospective, double blind, randomized, controlled study of 260 adults with uncomplicated acute corneal injuries presenting to the tertiary acute care settings in Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in addition to usual care as outpatients. They will be followed through the ophthalmology emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing, use of adjunct pain medications, time lost from work/usual activities, quality of sleep, ability to read and the SF12 quality of life questionnaire.

This study will better inform the safety and effectiveness of short-term tetracaine usage in patients with simple corneal abrasions for optimal treatment of patients in the future.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Treatments: Ophthalmic Solutions; Tetracaine

Criteria

Inclusion Criteria:

• Patients (>18yo) coming in with acute (<24 hours) simple uncomplicated corneal abrasions.

Exclusion Criteria:

1. Patients with frankly contaminated wound, corneal foreign body, or epithelial defect secondary to contact lens wear

2. History of comorbid eye conditions including eye surgery within the past month and glaucoma.

3. Involvement of both eyes

4. Allergy to tetracaine or any of the substances used in the study

5. Unable to provide consent.

6. Unable to come for follow-up.

7. Patients with a past history of corneal injury infection or surgery will undergo a screening test of the corneal sensation. If a diminished or absent sensation is found, the patient will be excluded from the study.