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临床试验/NCT03067077
NCT03067077已完成不适用

A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery

Stanford University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2017年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better

研究概览

简要总结

Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.

详细描述

Subjects 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 subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE 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
22 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
  • •Subjects with up to 3.00 diopters of astigmatism.

排除标准

  • •Subjects under the age of
  • •Subjects with excessively thin corneas.
  • •Subjects with topographic evidence of keratoconus.
  • •Subjects with ectatic eye disorders.
  • •Subjects with autoimmune diseases.
  • •Subjects who are pregnant or nursing.
  • •Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
  • •Subjects with 3.25 or more diopters of astigmatism
  • •Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.

研究组 & 干预措施

SMILE

Active Comparator

SMILE surgery

干预措施: LASIK (Procedure)

SMILE

Active Comparator

SMILE surgery

干预措施: SMILE (Procedure)

Wavefront-guided LASIK

Active Comparator

Wavefront-guided LASIK

干预措施: SMILE (Procedure)

Wavefront-guided LASIK

Active Comparator

Wavefront-guided LASIK

干预措施: LASIK (Procedure)

结局指标

主要结局

Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better

时间窗: One year

ETDRS testing lane

次要结局

  • Anterior Segment Ocular Coherence Topography Analysis(One year)
  • Patient Satisfaction(One year)
  • Change in Corneal Sensation(One year)
  • Dry Eye Symptoms as Measured by OSDI Index(One year)
  • Analysis of Astigmatism(One year)
  • Predictability(One year)
  • Stability(One year)
  • Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity(One year)
  • Aberrometry Measurements(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward E. Manche

Professor of Ophthalmology

Stanford University

研究点 (1)

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