Randomized, Controlled Treatment With an Intracanalicular Dexamethasone (0.4mg) Insert Following Cataract Surgery With IOL Combined With MIGS, Specifically iStent, iStent Inject or KDB in Patients With POAG or Ocular Hypertension (OHTN)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery
研究概览
简要总结
Randomized, controlled treatment with an intracanalicular dexamethasone (0.4mg) insert following cataract surgery with intraocular lens implant (IOL) combined with minimally invasive glaucoma surgery (MIGS), specifically iStent, iStent inject or KDB in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHTN)
详细描述
To determine treatment and patient reported outcomes, following cataract surgery with intraocular lens implant in conjunction with minimally invasive glaucoma surgery (MIGS) more specifically iStent, iStent inject or KDB with an intracanalicular dexamethasone (0.4 mg) insert, inserted four days (+/- 1 day) prior to surgery as compared to insertion on day of surgery. Patients with either primary open angle glaucoma (POAG) or ocular hypertension (OHTN) requiring cataract surgery with IOL implant, will be separated into two groups.
Group 1: intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery) Group 2: intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
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
- 是
入选标准
- •Age 18 years and older
- •Been diagnosed with POAG or OHTN and MIGS (iStent, iStent inject or KDB) has been planned
- •Unilateral or bilateral cataract surgery with IOL has been planned
- •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
- •Unobstructed nasolacrimal duct in the study eye(s)
- •Hypersensitivity to dexamethasone
- •Patients being treated with immunomodulating agents in the study eye(s)
- •History of prior ocular surgery, including Lasik or PRK
- •History of ocular inflammation or macular edema
- •Patients being treated with >375mg daily of NSAIDs
- •o Patients on doses higher than 375mg of oral NSAIDs will be considered if they discontinue the medication 2 weeks prior to the study start date.
- •Patients taking inconsistent varying doses of an NSAID on a daily basis.
- •Patients being treated with immunosuppressants and/or oral steroids
- •Patients with a corticosteroid implant (i.e. Ozurdex)
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
Insertion visit 4 days prior
Intracanalicular dexamethasone (0.4 mg) insertion four days (+/- 1 day) prior to cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
干预措施: Intracanalicular Dexamethasone, 0.4 mg insert (Drug)
Surgical 1 visit day 0
Intracanalicular dexamethasone (0.4 mg) insertion on the day of cataract surgery with intraocular lens (IOL) implant and MIGS (iStent, iStent inject or KDB) insertion. (Patient to use antibiotic three days prior to surgery)
干预措施: Intracanalicular Dexamethasone, 0.4 mg insert (Drug)
结局指标
主要结局
Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery
时间窗: four days (+/- 1 day) prior to surgery with visits scheduled at day 1, day 7, day 14, day 30, and day 45.
Primary: Will receive the insert four days (+/- 1 day) prior to surgery. Each enrolled subject will be required to complete seven scheduled visits over the course of the study period: Baseline, insertion visit, operative visit, Day 1, 7, 30, and a 14 \& 45-day phone call. Absence of cells in anterior chamber at day 7 as measured by: Summed Ocular Inflammation Score (0-4) Absence of cell to be defined as a grade of (0-0.5) Absence of pain at Day 7 (score of 0) as measured by ocular pain assessment numerical grading scale 0-10 Mean change in BCVA from baseline (Day 7,30) Mean change in OCT from baseline (Day 30) Physician ease of intracanalicular insertion evaluation as measured by physician questionnaire Incidence and severity of ocular and systemic AE's (Day 1,7,14,30,45)
次要结局
- Intracanalicular Dexamethasone, 0.4 mg insertion on day of surgery.(insertion on day of surgery with scheduled visits on day 1, day 7, day 14, day 30, and day 45.)