Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) at 1 and 3 Months
研究概览
简要总结
In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.
详细描述
Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract surgery candidate and glaucoma present in at least one eye.
- •Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation.
排除标准
- •Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
- •Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
- •Anterior chamber cells present at time of enrollment
- •Recent febrile illness that precludes or delays participation for 3 months
- •Pregnancy or lactation
- •Known allergy to dexamethasone
- •Known allergy to prednisolone
- •Treatment with another investigational drug within the last 20 years
- •Current recreational drug use
- •Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
- •Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior
研究组 & 干预措施
DEXTENZA® arm
This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.
干预措施: Dexamethasone Ophthalmic Insert (Drug)
Prednisolone acetate 1% arm
This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) at 1 and 3 Months
时间窗: 1 month postop, 3 months postop
Using quantitative IOP readings to compare ocular safety between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months
时间窗: 1 month postop, 3 months postop
Using quantitative BCVA measurements, as determined by ETDRS chart at 4 meters, to compare ocular safety and effectiveness between arms. Since the outcome examined was a "change," baseline, month 1 postop, and month 3 postop data were used in the calculations. 1 month change calculation: Month 1 postop value - Baseline value 3 month change calculation: Month 3 postop value - Baseline value
Difference in Eyes With Adverse Events Between Groups
时间窗: Up to 3 months postop
Using the average number of eyes with adverse events that occur in each arm to compare safety between arms through 3 months of postoperative follow-up
Difference in Number of Glaucoma Medications at 3 Months
时间窗: 3 months postop
Using the average number of glaucoma medications added or subtracted to each arm to compare safety between arms. These calculations were performed by subtracting the baseline glaucoma medications from the glaucoma medications at month 3.
次要结局
- Difference in Ocular Comfort Index (OCI) Score at 1 Month(1 month postop)
- Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)(3 months postop)
- Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops(Up to 3 months postop)
- Difference in Ocular Comfort Index (OCI) Score at 3 Months(3 months postop)
- Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month(1 month postop)
研究者
Nathan M. Radcliffe, MD
Dr. Nathan M. Radcliffe, Attending Ophthalmologist
The New York Eye Surgery Center