Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess control of inflammation following the vitreoretinal surgical procedure.
研究概览
简要总结
This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group.
Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
详细描述
Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.
The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Only the readers of the anterior segment OCT will be masked.
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
- •Men and women >18 years old
- •Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.
排除标准
- •Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system
- •History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye
- •Structural lid abnormalities such as ectropion or entropion in surgical eye
- •Ongoing use of systemic narcotic pain relievers
- •Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
- •Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
- •Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
- •Other ocular surgeries or procedures during the study period and/or 6 months prior
- •Intraoperative complications
- •Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
- •Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
- •Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
- •Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
- •Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
- •Are pregnant or nursing/lactating
- •Participation as a subject in any clinical study within the 30 days prior to randomization.
- •Surgeries using 20 gauge or 23 gauge instruments.
研究组 & 干预措施
Topical steroid drop group
This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
Intracanalicular dexamethasone insert group
This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.
干预措施: Dexamethasone Ophthalmic Insert (Drug)
结局指标
主要结局
To assess control of inflammation following the vitreoretinal surgical procedure.
时间窗: day 14 following surgery
Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature \[SUN\] Working Group grading scheme at day 14
次要结局
- Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.(days 1, 7, 14, and 21 following surgery)
- The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.(days 1, 3, 7, 14, and 21 following surgery)
- The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.(day 21 following surgery)
- Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.(day 21 following surgery)
- % of patients receiving rescue treatment.(days 1, 7, 14, and 21 following surgery)
- % of patients with postoperative management via telephone or electronic messaging(day 21 following surgery)
- % of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.(day 21 following surgery)
研究者
Katherine Talcott
Principal Investigator
The Cleveland Clinic