Corneal Abrasion
Conditions
Brief summary
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.
Interventions
DEVICEAir Optix contact lens
Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Superficial Corneal Abrasion
Exclusion criteria
* Incarceration * Pregnancy * Inability to Provide Informed Consent * Infectious keratitis * Retained foreign bodies in the eye * Active infection involving the orbit or periorbital region * Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology * A history or recent contact lens wear * A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion * Allergy to the antimicrobial solution (POLYTRIM) * Women who are currently breastfeeding * Chronic eye drop use * A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion) * Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing) * Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge | Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bandage Contact Lens (BCL) Group Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye
Air Optix contact lens: Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage | 1 |
| Usual Care Group Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Bandage Contact Lens (BCL) Group | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Change in Pain Score
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Time frame: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Population: Study terminated due to change in practice decreasing availability of eligible patients. Data was not collected or analyzed.