Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Estimated fluid usage- Low IOP Group
研究概览
简要总结
The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).
详细描述
To investigate the anterior and posterior physiological changes when performing phacoemulsification at high IOP vs low, more physiologic IOP using Centurion® Vision System with Active Sentry® handpiece
Prospective, single-surgeon, randomized, paired-eye study; patients undergoing sequential, uncomplicated bilateral phacoemulsification using Active Sentry handpiece® with intraocular IOP ≤ 28mmHg (low IOP) in one eye and with IOP ≥ 60mmHg (high IOP) in the other eye
Operating at lower, more physiological IOP using Active Sentry® handpiece during cataract surgery will use less BSS fluid usage. (Lower IOP settings are also expected to result in less subclinical changes).
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
- 是
入选标准
- •No prior ocular surgery including corneal refractive surgery
- •Bilateral visually significant cataract, similar in density (LOCS III grade 2+), undergoing uncomplicated cataract surgery
- •Equal dilated pupil size ≥6mm, no use of pupil expansion devices
- •Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension with normal OCT angiography at baseline
- •A1C ≤ 8% on single monotherapy or lifestyle adjustments
- •To maintain high sensitivity/specificity, patients to fall under OCT normative database:
- •Axial length 22-26mm
- •Refractive error between -5.00D to +5.00D
- •Cylinder ≤ 3.00D
- •Normal K values <47.00D
- •Axial eye length cannot vary by more than 0.4 mm in an individual patient
- •Normal CCT range 540µm ± 50
排除标准
- •H/o corneal disease or dystrophies
- •Media opacification for reasons other than cataract
- •Compromised zonular integrity or stability
- •Retinal and retinal vascular pathologies, age-related macular degeneration
- •Patients with uncontrolled systematic diseases; including hypertension, diabetes, systemic cardiovascular diseases and hematological diseases
结局指标
主要结局
Estimated fluid usage- Low IOP Group
时间窗: Intraoperative
Measurement of fluid usage (ml).
Estimated fluid usage- High IOP Group
时间窗: Intraoperative
Measurement of fluid usage (ml).
次要结局
- Corneal Thickness(post procedure at 1 day, 1 week, 1 month, and 3 months)
- Macular Thickness(post procedure at 1 week, 1 month, and 3 months)
研究者
Matthew Rauen
MD
Wolfe Eye Clinic