A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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 determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
详细描述
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
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
- 18 Years 至 —（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 PRK 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
- •Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- •Active infectious ocular or systemic disease.
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- •Patients with known hypersensitivity to Dexamethasone.
- •Patients with severe disease that warrants critical attention, 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) greater than 1,200 mg/day
- •Patients with a corticosteroid implant (i.e. Ozurdex).
- •Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes.
- •Patients who do not have 20/20 snellen visual acuity potential pre-operatively.
- •MRSE greater than 6 diopters.
- •Greater than 2 diopters anisometropia.
研究组 & 干预措施
Group A Dextenza
Will receive Dextenza post-operative
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group B Topical Prednisolone
Will receive standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week
干预措施: Topical Prednisolone (Drug)
结局指标
主要结局
Patient Preference
时间窗: Through Month 1 (Day 28 +/- 3 days)
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
次要结局
- Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)(Day 3)
- Percentage of Eyes Fully Epithelialized at Day 4 Postoperative(Postoperative Day 4)
- Percentage of Eyes Epithelialized at Day 3(Post-Operative Day 3)
- Uncorrected Distance Visual Acuity(Month 1 and Month 3.)
- Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative(Month 1 and Month 3)
- SPEED Questionnaire Results at Baseline and Postoperative Day 28(Pre-op Visit and Month 1 (Day 28))
研究者
Tiffany Facile
Principal Investigator
Vance Thompson Vision