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临床试验/NCT06219252
NCT06219252招募中不适用

Intraoperative Aberrometry vs Conventional Introcular Lens Calculation ( Barrett Universal II / Barrett True K ), Refractive and Visual Outcomes, a Prospective Study.

Instituto de Oftalmología Fundación Conde de Valenciana2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
spherical equivalent

研究概览

简要总结

the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .

Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity

详细描述

Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.

The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

None of the patients will be informed in what group they are assigned

入排标准

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

入选标准

  • patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.

排除标准

  • glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.

结局指标

主要结局

spherical equivalent

时间窗: 90 days of the postoperative period

Spherical equivalent values at 90 days of the postoperative period

次要结局

  • uncorrected distance visual acuity(90 days of the postoperative period)

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (2)

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