Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Primary Purpose
Corneal Abrasion
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tetracaine 0.5% ophthalmic drops
Normal Saline placebo drops
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Abrasion
Eligibility Criteria
Inclusion Criteria:
- Patients (>18yo) coming in with acute (<24 hours) simple uncomplicated corneal abrasions.
Exclusion Criteria:
- Patients with frankly contaminated wound, corneal foreign body, or epithelial defect secondary to contact lens wear
- History of comorbid eye conditions including eye surgery within the past month and glaucoma.
- Involvement of both eyes
- Allergy to tetracaine or any of the substances used in the study
- Unable to provide consent.
- Unable to come for follow-up.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tetracaine 0.5% ophthalmic drops
placebo (Normal Saline placebo drops)
Arm Description
0.8 mls. drops provided to be used hourly p.r.n. for pain control
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Outcomes
Primary Outcome Measures
pain control as measured by visual analogue score
10 cm. VAS scale
Secondary Outcome Measures
Compound Outcome comprised of Number of Participants with one or more of listed adverse outcomes including: anaphylactic reaction, infectious infiltrate, stromal/ring infiltrate, corneal ulceration, hypopyon, abrasion size not decreasing
adverse outcome measure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02483897
Brief Title
Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Official Title
Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
inabililty to recruit at required rate
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Corneal abrasions are commonly encountered eye injuries presenting to acute care settings and account for over 10% of new ophthalmological presentations at eye accident departments, primary care offices, and emergency departments. Patients complain of severe eye pain, foreign body sensation, pain with blinking, and photophobia. Corneal abrasions are defects in the epithelial layer that occur secondary to mechanical ocular surface trauma. Common causes of corneal abrasions include fingernail injuries, tree branches, and projectile pieces of metal, wood, or glass that injure or become embedded in the cornea. . Though associated with significant discomfort, the prognosis for simple corneal abrasions is usually excellent, with full recovery within 24-48 hours. Untreated abrasions, particularly those associated with a retained foreign body, can lead to complications such as corneal ulcers, prolonged pain, and visual acuity loss.
Currently, the standard approach to treating corneal abrasions includes removal of the foreign body if present, oral analgesics for pain control, and topical antibiotics. Traditional guidelines by ophthalmologists have advocated against the use of topical anesthetics due to concerns with corneal epithelial healing the potential for patients to miss important clinical clues that indicate the rare development of secondary corneal infection, as well as the potential for longer term misuse leading to severe corneal ulceration and perforation. Previous studies, primarily using animal models, have found a delay in corneal epithelial healing with topical anaesthetics, particularly with repeated and prolonged usage. Several case studies have described impaired corneal epithelial healing and ulceration with the prolonged use and abuse of topical anesthetic drops (0.05% proparacaine HCl). There have been reports of topical anesthetic (TA) induced corneal damage including punctate epitheliopathy, corneal lysis, perforation, persistent epithelial defects, and ocular inflammation. It is thought that local anesthetics inhibit mitosis and cellular migration, preventing proper re-epithelialization of the cornea.
However, in recent years a number of randomized clinical trials and case studies of human subjects have shown that with appropriate application and restricted short term usage, topical anesthetics did not delay wound healing or increase risks of corneal ulceration.
A recent prospective, randomized, double-blind trial looked at the effect of topical anesthetics on epithelial healing and pain management for patients with uncomplicated corneal abrasion. The study included 116 patients presenting to the emergency department who were given either 1% tetracaine HCl or control artificial tears. The study found no change in corneal healing rate or persistent symptoms but little benefit in pain relief as measured at 48 hrs. A previous prospective randomized study comparing 0.05% proparacaine and placebo has shown a significant decrease in reported pain with topical anesthetic use compared to control with no change in corneal healing. Another study evaluating the effect of 1% tetracaine for pain management after photorefractive keratectomy also reported significant pain reduction with topical anesthetic use with no delays in epithelial healing.
Controversy continues to exist over the utility of topical anesthetics in managing pain and their safety in affecting corneal healing. Contemporary studies of short term topical anesthetic use, noted above, have not shown adverse effects on healing. Differential effects on pain management have been found. Yet the investigators believe the Waldman study measured pain at a delayed time when the abrasion would be expected to have healed. Clinicians in Queen's Department of Emergency Medicine do not generally prescribe topical anesthetics for corneal abrasions and believe that evidence demonstrating their efficacy and safety would change practice patterns for the benefit of patients with these injuries and those in other centres. The investigators also hope that this study will better address problems of inadequate participant enrollment and retention that previous studies have encountered.
1.3 - Research Question In adult emergency department patients with acute corneal abrasions, is the application of 0.5% tetracaine effective in the short-term management of pain while not being associated with adverse effects on healing?
1.4 - Hypothesis Based on the review of existing literature on the effects of topical anesthetics, the investigators hypothesize that short-term and controlled usage of tetracaine will be an effective way in managing patient pain and will not affect corneal healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Abrasion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetracaine 0.5% ophthalmic drops
Arm Type
Experimental
Arm Description
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Arm Title
placebo (Normal Saline placebo drops)
Arm Type
Placebo Comparator
Arm Description
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Intervention Type
Drug
Intervention Name(s)
Tetracaine 0.5% ophthalmic drops
Intervention Description
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Intervention Type
Drug
Intervention Name(s)
Normal Saline placebo drops
Intervention Description
0.8 mls. drops provided to be used hourly p.r.n. for pain control
Primary Outcome Measure Information:
Title
pain control as measured by visual analogue score
Description
10 cm. VAS scale
Time Frame
at 12 hours post baseline
Secondary Outcome Measure Information:
Title
Compound Outcome comprised of Number of Participants with one or more of listed adverse outcomes including: anaphylactic reaction, infectious infiltrate, stromal/ring infiltrate, corneal ulceration, hypopyon, abrasion size not decreasing
Description
adverse outcome measure
Time Frame
at 36-48 hour follow up appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients (>18yo) coming in with acute (<24 hours) simple uncomplicated corneal abrasions.
Exclusion Criteria:
Patients with frankly contaminated wound, corneal foreign body, or epithelial defect secondary to contact lens wear
History of comorbid eye conditions including eye surgery within the past month and glaucoma.
Involvement of both eyes
Allergy to tetracaine or any of the substances used in the study
Unable to provide consent.
Unable to come for follow-up.
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
35622535
Citation
Algarni AM, Guyatt GH, Turner A, Alamri S. Antibiotic prophylaxis for corneal abrasion. Cochrane Database Syst Rev. 2022 May 27;5(5):CD014617. doi: 10.1002/14651858.CD014617.pub2.
Results Reference
derived
Learn more about this trial
Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
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