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临床试验/NCT03063164
NCT03063164已完成不适用

A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax

Edward E. Manche2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7
试验地点
2
主要终点
ETDRS Uncorrected Visual Acuity

研究概览

简要总结

Comparing LASIK outcomes using two femtosecond lasers

详细描述

Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

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
None

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

排除标准

  • Subjects under the age of 21
  • Subjects over the age of 60
  • Subjects with corneal ectatic disorders

结局指标

主要结局

ETDRS Uncorrected Visual Acuity

时间窗: At post-operative month 12

Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

次要结局

  • Best Spectacle Corrected Visual Acuity(Postoperative month 12)
  • Cochet Bonnet Asthesiometry Measurement of Corneal Sensation(At postoperative month twelve)
  • Aberrometry(One three, six and twelve months)
  • Patient Reported Outcomes With LASIK(One month, three months, six months and twelve months)
  • Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness(At postoperative month one)
  • Questionnaire Measuring Patient Preference for Laser Device(Intraoperative (Approximately 1 minute after completion of surgery))

研究者

发起方
Edward E. Manche
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward E. Manche

Professor of Ophthalmology

Stanford University

研究点 (2)

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