Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in Pain
研究概览
简要总结
This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion
详细描述
4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.
4.1.1 Inclusion Criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- Age 18 years and older
- Scheduled for bilateral SMILE surgery
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
4.1.2 Exclusion Criteria
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
- None
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
- •Age 18 years and older
- •Scheduled for bilateral SMILE surgery
- •Willing and able to comply with clinic visits and study related procedures
- •Willing and able to sign the informed consent form
排除标准
- •Patients under the age of
- •Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- •Active infectious systemic disease
- •Active infectious ocular or extraocular disease
- •Obstructed nasolacrimal duct in the study eye(s)
- •Hypersensitivity to dexamethasone
- •Patients being treated with immunomodulating agents in the study eye(s)
- •Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Dexamethasone ophthalmic insert 0.4 mg
Dexamethasone ophthalmic insert 0.4 mg
干预措施: Dexamethasone ophthalmic insert 0.4 mg (Drug)
Topical prednisolone acetate ophthalmic drops
topical prednisolone acetate ophthalmic drops
干预措施: Topical Prednisolone Acetate Ophthalmic Drops (Drug)
结局指标
主要结局
Mean Change in Pain
时间窗: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90
post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)
次要结局
- Post op Pain Management Per Eye(Day 0 to Day 90)
- Patient Preference Between Groups(Day 7, Day 30 and Day 90)
- Number of Lines Lost From Best Corrected Visual Acuity(Baseline through Day 90)
- Loss of Lines in Uncorrected Visual Acuity(Baseline to Day 7, Day 30 and Day 90)
研究者
William Wiley, MD
Principal Investigator
Cleveland Eye Clinic