Bandage Contact Lenses for Corneal Abrasions

Study Overview
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Brief Summary
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Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.

Official Title
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Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions

Conditions
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Corneal Abrasion, Eye Trauma

Intervention / Treatment
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* Device: Bandage contact lens
* Drug: Eyedrop
* Drug: Hydrocodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between ages 18-65 years who present to the emergency department. Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye. Exclusion Criteria: Pregnant women Breast-feeding women Corneal abrasion associated with the wearing contact lenses Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision Wound healing deficits such as collagen vascular disease or concomitant steroid use Use of other ocular medications, dry eyes, blepharitis Systemic infections Known allergies to medicines used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>1. Standard care | Drug: Eyedrop<br>* Fluoroquinolone eyedrops 4x/day<br>Drug: Hydrocodone<br>* Hydrocone 1-2 tabs 4x/day if needed<br>|
| Active Comparator: Group 2<br>Standard care Bandage contact lens | Device: Bandage contact lens<br>* Bandage contact lenses (BCL) have the advantage of pain reduction, facilitating epithelial healing, and improved surface healing. They have been used in the ophthalmology community to treat post-operative eye pain due to the large corneal abrasion created during Excimer photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), and radial keratotomy (RK) with good success. Bandage contact lenses have also been used in studies in Europe through ophthalmology clinics to treat traumatic corneal abrasions with excellent results. A British study from 1987, found that large diameter contact lenses can be fitted satisfactorily without the use of special equipment such as keratometry. Studies in rabbits have also been performed showing improved rates of healing when using bandage contact lenses. BCLs have been used to treat epithelial defects from various causes for up to 7 months at a time.<br>Drug: Eyedrop<br>* Fluoroquinolone eyedrops 4x/day<br>Drug: Hydrocodone<br>* Hydrocone 1-2 tabs 4x/day if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale | The pain difference using Visual Analogue Scale | 24 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal defect size | Reduction in size (mm) of the defect | 24 hours post treatment | 
| Pain medication needed | The amount of pain medication needed | 24 hours post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corneal abrasion, contact lens, eye trauma