Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups
研究概览
简要总结
The goal of this observational study is to learn about the long-term results of glaucoma stent surgery in men and women 18 or older who have had cataract and microstent surgery in the past 2 years at the Moran Eye Center. The main questions the study aims to answer are:
- How often are microstents mispositioned?
- What effect does microstent positioning have on intraocular pressure after surgery?
Participants will have a one-time clinic visit for an eye exam and Optical Coherence Tomography (OCT) .
From the eye exam and OCT, Researchers will assess and categorize the position of the microstents and assess the Schlemm's canal dilation.
Researchers will review the participants' medical records to acquire 2-year data for the following:
- Surgeon type and level of experience (resident, fellow, attending ophthalmologist)
- Proportions of proper gonioscopic placement intraoperatively for each surgeon group
- Effectiveness of surgery, based on change in intraocular pressure (IOP) from baseline medicated IOP, number of IOP-lowering medications the patient was able to discontinue, and rate of need for additional glaucoma surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center.
排除标准
- •Any patient who subsequently had to have their stent removed for any reason, any patient with a history of trauma to the anterior segment or reconstruction altering typical anatomy.
结局指标
主要结局
Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups
时间窗: Two years post stent placement
Positioning of each participant's stent(s) will be evaluated by anterior segment OCT at the one-time clinical study visit. iStent Inject W mispositions are defined as: microstent protrusion (entire conical head not within canal), stent completely buried in the trabeculae, or not seen (i.e. 0 or only 1 stent). If the iStent position is located but the examiner is unsure if it is positioned correctly, it will be counted as misposition. If the iStent is not seen, an in office gonioscopy will be performed to confirm results. Visualization of three stents is not considered a misposition. Hydrus mispositions are defined as: distal tip not in canal, at least 1 window not in canal, or trabecular microstent not within transition zone. The between group difference of mispositioned stents will be calculated in percentage.
次要结局
- Dilation of Schlemm's canal(Two years post stent placement)
- Change in IOP from baseline(Two years post stent placement)
- Reduction in number of IOP lowering medications(Two years post stent placement)
- Percentage of patients needing additional glaucoma surgery(Two years post stent placement)
- Sub-analysis of primary outcome by surgeon type(Two years post stent placement)
- Proportion of stent cases with proper placement via anterior segment OCT versus proportion of cases with proper placement via intraoperative gonioscopy(Two years post stent placement)
研究者
Rachel Simpson
Assistant Professor (Clinical)
University of Utah