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临床试验/NCT00803478
NCT00803478撤回不适用

The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure

University of Michigan2 个研究点 分布在 1 个国家开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.

研究概览

简要总结

Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported in as many as 59% of patients. And almost all patients have some transient dry eye symptoms immediately following LASIK.

Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome. Corneal sensation was decreased and dry eye signs and symptoms increased immediately following LASIK in all eyes. These parameters then improved at all time periods between 1 week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become an increasingly popular procedure. It provides several advantages over mechanical microkeratomes, including reduced surgical complications, more predictable flap thickness, better astigmatic neutrality, decreased epithelial injury, and an ability to operate on a wider range of patients.

The investigators propose this study to evaluate the effect of flap hinge size and flap thickness in corneal flaps created with the IntraLase laser. The investigators would like to determine if there is a difference from the previously discussed results found when using the mechanical microkeratome. Also, with the increased ease of programming alternate hinge width or flap thickness with IntraLase, if the investigators find a significant difference with an alternate flap configuration, it might translate to a feasible change in clinical practice.

详细描述

Corneal innervation/sensation is supplied by the long ciliary nerves which branch from the trigeminal nerve. The nerves enter the cornea in the mid-stroma at the nasal and temporal limbus. They then branch and turn anterior to form a dense plexus sub-Bowman's layer. The nerves finally terminate in the wing cell layer from where they enervate the epithelium. Corneal sensation has been shown to be decreased after all corneal surgeries, including LASIK.

Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported in as many as 59% of patients. And almost all patients have some transient dry eye symptoms immediately following LASIK.

Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome.1,2 Corneal sensation was decreased and dry eye signs and symptoms increased immediately following LASIK in all eyes. These parameters then improved at all time periods between 1 week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become an increasingly popular procedure. It provides several advantages over mechanical microkeratomes, including reduced surgical complications, more predictable flap thickness, better astigmatic neutrality, decreased epithelial injury,3 and an ability to operate on a wider range of patients.

We propose this study to evaluate the effect of flap hinge position and size in corneal flaps created with the IntraLase laser. We would like to determine if there is a difference from the previously discussed results found when using the mechanical microkeratome. Also, with the increased ease of programming alternate hinge position and width with IntraLase, if we find a significant difference with an alternate flap configuration, it might translate to a feasible change in clinical practice.

Specific Aims: To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.

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
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Refractive error: Myopia < 12 D, with astigmatism < 3 D,
  • Age > 20 y/o
  • Regular corneal curvature, sufficient corneal thickness, appropriate pupil size, normal slit lamp examination
  • Informed consent to permit us to use their records for this study without using name, medical record number, or date of surgery.

排除标准

  • Pregnant/nursing
  • Systemic collagen vascular disease
  • Autoimmune disease
  • Severe dry eyes

结局指标

主要结局

To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.

时间窗: pre operative and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months post-operative

次要结局

未报告次要终点

研究者

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

Shahzad Mian

erry J Bergstrom Collegiate Professor of Resident Education in Ophthalmology and Visual Sciences and Associate Professor of Oph, Ophthalmology & Visual Science

University of Michigan

研究点 (2)

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