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临床试验/NCT07425496
NCT07425496招募中不适用

Dynamic Ocular Tonometry Study During Intraocular Surgery

The New York Eye & Ear Infirmary1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Intraocular Pressure (IOP) measurement calculation during surgery.

研究概览

简要总结

The objective of this study is to evaluate ocular outflow dynamics of the eye using intraoperative tonographic biometry and assess its predictive value in improving postoperative outcomes.

详细描述

This study proposes to measure the intraocular pressure (IOP), ocular fluid dynamics and outflow homeostasis in patients undergoing intraocular surgery to understand how post-operative surgical success can be optimized and complications prevented.

This is a prospective observational study, single study arm and at a single-site. Recruitment will be from physicians affiliated with the Mount Sinai Health System who are performing intraocular surgeries, such as cataract and/or glaucoma surgeries. Intraocular pressure measurements will be taken using an FDA-registered, sterile, single-use, disposable Deltran I pressure sensor designed for measuring physiological pressures of the body to obtain concomitant intraocular measurement and outflow capacity calculation during the surgery. Monitoring intra ocular pressure postoperatively for up to 90 days.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals undergoing cataract and/or glaucoma surgery in the Mount Sinai Health System.

排除标准

  • Individuals less than 18 years old, pregnant women, those without capacity to make their own decisions, and prisoners.

研究组 & 干预措施

Cataract

disposable Deltran I pressure sensor for Cataract

干预措施: disposable Deltran I pressure sensor (Diagnostic Test)

Glaucoma

disposable Deltran I pressure sensor for Glaucoma

干预措施: disposable Deltran I pressure sensor (Diagnostic Test)

结局指标

主要结局

Intraocular Pressure (IOP) measurement calculation during surgery.

时间窗: 90 days

Measure the intra ocular pressure measurement during surgery to better inform surgeons of post-operative management and outcomes.

Outflow capacity calculation during surgery

时间窗: 90 days

Measure the outflow capacity rate measurement during surgery to better inform surgeons of post-operative management and outcomes.

次要结局

  • Rate of intraoperative and postoperative complications.(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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