Bandage Contact Lenses for Corneal Abrasions

Phase 2UnknownNCT03206723

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Corneal Abrasion Eye Trauma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain scale

The pain difference using Visual Analogue Scale

Time frame: 24 hours post treatment

Secondary Outcomes

Corneal defect size

Reduction in size (mm) of the defect

Time frame: 24 hours post treatment

Pain medication needed

The amount of pain medication needed

Time frame: 24 hours post treatment

Bandage Contact Lenses for Corneal Abrasions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts