DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
研究概览
简要总结
The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.
详细描述
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background diabetic retinopathy undergoing cataract surgery treated with a 0.4mg dexamethasone intracanalicular insert when compared to standard of care prednisolone acetate 1% QID/1 week, TID/ 1 week, BID/ 1 week, QD/1 week. Topical NSAIDs will not be used in this study and all patients will receive an intracameral injection of moxifloxacin at the end of the surgical procedure. After screening a patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo cataract surgery on separate days. The second eye will be operated on within 60 days of the first eye's surgery. One eye will be randomized to receive the dexamethasone insert using a coin flip. The other eye will be prescribed a prednisolone acetate 0.1% eye drop QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen. The dexamethasone insert will be placed 2-4 days before surgery (Day -4 to Day-2) and those randomized to receive prednisolone acetate will start 2-4 days before surgery. After surgery, each eye will be followed for a period of approximately 60 days, consisting of four post-op follow-up visits (eight total post-op visits per patient). Primary and secondary endpoints will be assessed alongside standard-of-care procedures at all study visits . Adjusting for the enrollment period, the study will last a total of approximately 12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Binocular
- •>18 years old
- •Any level of Background Diabetic Retinopathy
- •Cataract surgery candidate in each eye
- •Pre-operative OCT and Fluorescein Angiography showing no Macular edema
排除标准
- •Participant cannot complete second eye operation within 60 days of the first cataract surgery
- •Maintains regular use of systemic or ocular steroids at time of enrollment
- •Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
- •Anterior chamber cells present at time of enrollment
- •Recent febrile illness that precludes or delays participation for 90 days
- •Pregnancy or lactation
- •Known allergy to dexamethasone
- •Known allergy to prednisolone
- •Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
- •Posterior capsule rupture or other intraoperative complication in first eye operated on
- •Amblyopia
- •Anti-VEGF injections within 6 months prior to surgery day.
- •Intraocular steroid injection within 6 months prior to surgery day.
- •Intraocular surgeries within 6 months prior to surgery day.
- •Laser photocoagulation within 30 days prior to surgery day.
- •Any type of eye inflammation
- •Any punctum inflammation or dacryocystitis
研究组 & 干预措施
Dextenza
Sustained release Dexamethasone 0.4mg
干预措施: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] (Drug)
Prednisolone Acetate 1%
Prednisolone Acetate Ophthalmic drops
干预措施: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] (Drug)
结局指标
主要结局
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
时间窗: 60 days
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.
次要结局
- Difference patients with absence of anterior chamber (AC) cells at Day 7 post op(7 days)
- Difference patients with absence of anterior chamber (AC) cells at Day 30 post op(30 days)
- Difference patients with absence of anterior chamber (AC) cells at Day 60 post op(30 days)
- Self reported patient experience of comfort(60 days)
- Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)(60 days)
- To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.(60 days)
- Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)(30 days)
- To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.(60 days)
- Rescue Therapy(60 days)