A Prospective Trial to Evaluate the Safety and Effectiveness of the Sustained Release Bimatoprost Implant With SpyGlass IOL in Patients With Ocular Hypertension or Mild to Moderate Open-Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6
研究概览
简要总结
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are:
- Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma?
- Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery?
- What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?
Participants will:
- Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.
- Complete a baseline visit to further evaluate eligibility in the study eye.
- Undergo standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated.
- Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).
详细描述
This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model. Participants will receive standard-of-care cataract extraction by phacoemulsification followed by implantation of the SpyGlass Bimatoprost Implant System / IOL Combination (low-dose cohort; medium-dose cohort; and high-dose cohort). The primary endpoint was measured at 6 months. There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation. Participants in this clinical study are seen for the following visits: a Screening visit, an Eligibility visit (Baseline), a Day 0 or Surgery visit, and postoperative visits at Day 1, Week 1, Month 1, Month 3, and Month 6 (Figure 1). Each participant has one eye designated as the study eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- •Planned removal of cataract
- •Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
排除标准
- •Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening
- •History of incisional/refractive corneal surgery
- •Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders
- •Other ocular diseases, pathology, or conditions
结局指标
主要结局
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6
时间窗: From Baseline until the end of post-operative follow-up at Month 6
The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.
Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6
时间窗: From Baseline until the end of post-operative follow-up at Month 6
The proportion of unmedicated eyes with IOP reduction of ≥ 20% from Baseline to the Month 6 exam.
次要结局
- Mean change in unmedicated IOP from Baseline to Month 6(From Baseline until the end of post-operative follow-up at Month 6)
- Number of topical glaucoma medications(From Screening until the end of post-operative follow-up at Month 6)
- Mean change in unmedicated IOP from Baseline to Month 6(From Baseline until the end of post-operative follow-up at Month 6)
- Number of topical glaucoma medications(From Screening until the end of post-operative follow-up at Month 6)