临床试验/NCT00365677

NCT00365677已完成不适用

Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment

Bausch & Lomb Incorporated0 个研究点目标入组 127 人开始时间: 2005年10月最近更新: 2011年12月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Bausch & Lomb Incorporated
入组人数: 127
主要终点: Uncorrected visual acuity

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.

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)

入排标准

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

入选标准

•Myopia with or without astigmatism.
•Normal Corneal topography
•Willing to have both eyes treated with the laser.

排除标准

•Contraindications to LASIK.

结局指标

主要结局

Uncorrected visual acuity

时间窗: At 90 days post surgery

Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.

时间窗: At 90 days post surgery

次要结局

Deviation from target correction(At 90 days post surgery)
Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline(At 90 days post surgery)

研究者

发起方

Bausch & Lomb Incorporated

申办方类型

Industry

责任方

Sponsor

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