A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient Preference
研究概览
简要总结
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.
详细描述
A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
- •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 22 or above the age of 75
- •Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
- •Paitents with know hypersensitivity to Dexamethasone
- •Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
- •Patients with a history of ocular inflammation or macular edema
- •Patients with allergy or inability to receive intracameral antibiotic
- •Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
- •Patient with a corticosteriod implant (i.e. Ozurdex).
- •Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
研究组 & 干预措施
Group A Dextenza
Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.
干预措施: Dextenza (Drug)
Group B Topical Prednisolone
Drug: Topical Prednisolone Standard of care topical drop treatment
干预措施: Topical Prednisolone (Drug)
结局指标
主要结局
Patient Preference
时间窗: Through Month 1
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)
次要结局
- Uncorrected Visual Acuity(Through Month 1)
- Best Corrected Visual Acuity(Through Month 1)
- Grade of post-operative corneal haze(Through Month 1)
- Percentage of eyes that have CME (Cystoid macular edema) post-operatively(Through Month 1)
- Mean pain score per eye (Group A vs Group B)(Through Month 1)
- Incidence of post-operative corneal haze(Through Month 1)
- Anterior chamber cell count(Through Month 1)