NCT07144644已完成不适用
Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Central Corneal Thickness
研究概览
简要总结
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period.
详细描述
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity in the post-operative period. By comparing these two different IOP settings, we can determine the impact of IOP on surgical efficiency and the quality of post-operative results, especially in relation to corneal health.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
- •Patients undergoing phacoemulsification surgery (OU) with or without femtosecond laser assistance (OU) with the Alcon Centurion system using Active Sentry handpieces (both eyes must undergo same treatment) . The cataract surgery and the use of the medical device(s) are planned by the principal investigator and are a part of regular care and are received regardless of being a part the study.
- •Patients expected to undergo sequential cataract surgery in both eyes within 6 weeks of each other.
- •Patients with the same LOCS III scale of nuclear portion of cataract in both eyes
- •Patients whose eyes will both be operated by the same surgeon using a similar Centurion machine with similar wound architecture and size, viscoelastic, technique, and postoperative medications.
- •Axial eye length cannot vary between eyes by more than 0.4 mm in an individual patient.
- •At least 30% of patients with PanOptix, 30% Vivity and 30% monofocal IOLs (no mix and match)
排除标准
- •Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect the surgical outcome measures.
- •Clinically significant ocular trauma.
- •Patients with unusually dense cataract (4+ nuclear sclerosis), zonular instability, or pseudoexfoliation syndrome
- •Patients requiring mechanical pupil expanding devices (iris hooks, Malyugin rings, etc.)
- •Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL)
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- •Reported pre-existing anxiety or pain disorder or history of psychiatric illness, chronic pain/narcotics, benzodiazepine usage.
- •Epitheliopathy/ Epithelial complications intraoperatively that may in the opinion of the investigator affect corneal densitometry or edema postoperatively.
- •Clinically significant IOL decentration
- •Vulnerable populations which includes, but is not limited to potential subjects who are children, prisoners, pregnant women, mentally disabled persons, and economically and educationally disadvantaged persons.
结局指标
主要结局
Central Corneal Thickness
时间窗: 1 day following surgery for each eye
Measurement by Pentacam
次要结局
- Total BSS fluid usage during phaco emulsification(Day of surgery for each eye)
- Ocular Inflammation(1 day following surgery for each eye)
- Aspiration time(Day of surgery for each eye)
研究者
研究点 (1)
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