IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oasis 72-Hour collagen shield, sham collagen shield.
- Who it may be relevant to
- Registry conditions: Corneal Abrasions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A SINGLE-CENTER, DOUBLE-ARM, PATIENT MASKED, PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO EVALUATE PATIENT REPORTED OUTCOMES IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
Overview
This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. One eye from each patient will be considered the study eye.
Interventions
- Device Oasis 72-Hour collagen shield
All qualified subjects will receive a drop of tetracaine. The treatment group will receive an Oasis 72-Hour collagen shield and instructions to take moxifloxacin 0.5% four times daily as well as ibuprofen 400 mg PO q4 hrs as needed for pain. - Device sham collagen shield
The control group will have a sham collagen shield placed (patient will have the impression a lens is placed but it will not actually remain on the eye), and will also be prescribed moxifloxacin 0.5% four times daily and ibuprofen 400 mg PO q4 hrs as needed for pain
Primary outcome measures
- Pain Score 4 hours [Time frame: four hours after leaving the emergency department.]
- Pain score 24 hours [Time frame: 24 hours after discharge from the emergency department]
- Pain Score 72 hours [Time frame: 72 hours after discharge from the emergency department]
Secondary outcome measures (3)
- Dosage NSAID use in first 24 hours [Time frame: in the first 24 hours after being discharged from the emergency department]
- Frequency NSAID 24 Hour [Time frame: 24 Hour]
- Pain score 24 hours [Time frame: 24 hours after discharge from the emergency department]
Eligibility criteria
Inclusion criteria
- Each of the following criteria must be met for study participation:
- Male or female, age 18 or older at the time of study enrollment.
- Corneal abrasion in one eye.
- Willingness to sign the IRB-approved informed consent form (ICF) for study participation.
- Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
Exclusion criteria
Patient candidates presenting any of the following characteristics will not be eligible for study participation:
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- Corneal abrasion in both eyes.
- Allergy to moxifloxacin or other fluoroquinolone antibiotics.
- Allergy to ibuprofen or other non-steroidal anti-inflammatory drugs.
- History of neurotrophic cornea for any reason, in the study eye.
- History of medical conditions known to cause decreased corneal sensation in the study eye including but not limited to HSV, HZO, and diabetes.
- History of extraocular surgical procedures known to cause decreased corneal sensation in the study eye, including but not limited to trigeminal nerve clamp.
- Any anterior segment pathology in the study eye that could significantly affect corneal wound healing (e.g. aniridia, clinically significant corneal dystrophies \[ABMD\], etc.)
- Any visually significant intraocular media opacity other than corneal abrasion in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.
- History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit visual acuity (e.g. ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).
- History of uveitis in either eye.
- History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), retinal barrier laser.
- Current ocular infection in the study eye.
- Presence of uncontrolled systemic disease that could limit capacity to sign consent or comply with treatment schedule (e.g. mental illness, dementia, etc.).
- Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07225699 · STUDY00027794