NCT07154810进行中（未招募）不适用
Observational Study to Evaluate Long-term Follow-up of Subjects Implanted With Sustained-release Bimatoprost With the SpyGlass IOL in Subjects With Ocular Hypertension or Mild-to-moderate Open-angle Glaucoma
SpyGlass Pharma, Inc.1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年3月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline
研究概览
简要总结
The goal of this clinical trial is to further observe and learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also further observe and 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 continue lower the pressure inside the eye to treat ocular hypertension or glaucoma long term?
- Does the Bimatoprost Implant System / IOL Combination continue to correct vision after cataract surgery long term?
- What long term medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to understand a written informed consent and be willing to participate by evidence of signing an informed consent form
- •Met all inclusion criteria, participated in and completed the SGP-SPEC-001 study
排除标准
- •Planned participation in another clinical trial within 30 days of the initial study visit that, in the investigator's opinion, could confound the study results
结局指标
主要结局
Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline
时间窗: From Month 9 post-operative through the end of post-operative follow-up at Month 84
The proportion of eyes that remain unmedicated and with an IOP reduction ≥ 20% from the SGP-SPEC-001 baseline visit for each follow-up time through the month 84 exam.
次要结局
未报告次要终点
研究者
研究点 (1)
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