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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain Score 4 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient candidates presenting any of the following characteristics will not be eligible for study participation:
- •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
研究组 & 干预措施
Treatment group (Oasis 72-Hour Collagen Shield)
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.
干预措施: Oasis 72-Hour collagen shield (Device)
Control Group ( 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.
干预措施: sham collagen shield (Device)
结局指标
主要结局
Pain Score 4 hours
时间窗: four hours after leaving the emergency department.
\- The primary endpoint will be pain score (10-point Liekert scale) 0=No pain 10=more pain
Pain score 24 hours
时间窗: 24 hours after discharge from the emergency department
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
Pain Score 72 hours
时间窗: 72 hours after discharge from the emergency department
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
次要结局
- Dosage NSAID use in first 24 hours(in the first 24 hours after being discharged from the emergency department)
- Frequency NSAID 24 Hour(24 Hour)
- Pain score 24 hours(24 hours after discharge from the emergency department)
研究者
Murtaza Akhter
Physician Scientist
Milton S. Hershey Medical Center