Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery for refractive error). Their use has decreased the incidence of serious complications when compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available and differs from the Intralase in that it does not interfere with the curvature of the cornea when creating the flap. The Intralase applanates the cornea flat during flap creation which causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the two lasers in a randomization of left and right eyes in the same patient. The investigators want to measure any difference that the lower intraocular pressure may have during the creation of the flap. This will be measured with a questionaire on patient experience during the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness measured with anterior segment OCT during the post-operative follow up period. To date no-one has compared the use of these two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older.
- •Cycloplegic spherical equivalent of >-1.00D
- •Refractive cylinder -4.00 D or less.
- •Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
- •Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
- •Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
- •No evidence of irregular astigmatism on corneal topography.
- •Available to attend post-operative examinations for a 3 month period.
排除标准
- •Progressive or unstable myopia and/or astigmatism.
- •Clinical or corneal topographic evidence of keratoconus.
- •Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
- •Previous corneal surgery or trauma within the corneal flap zone.
- •Patent corneal vascularization within 1mm of the corneal flap zone.
- •Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
- •Systemically immunocompromised.
- •Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
- •Pregnant or nursing.
研究组 & 干预措施
1 IntraLase flaps
Patients who have undergone flap creation with IntraLase laser
2 Visumax flaps
Patients who have undergone flaps created with Visumax laser
结局指标
主要结局
Visual Acuity
时间窗: 3 months
次要结局
- Subjective questionnaire(1 weekd)
- Corneal Sensation(3 months)
- complications(3 months)
- Contrast Sensitivity(3 months)
- Tear function(3 months)
- Wavefront analysis(3 months)
研究者
Jodhbir Mehta
Head Tissue Engineering and Stem Cell Group
Singapore Eye Research Institute