Effect of Preoperative Pupil Size on Quality of Vision After Wavefront-Guided LASIK
研究概览
详细说明
Purpose: To prospectively evaluate the effect of preoperative pupil size on quality of vision after wavefront-guided LASIK.
Methods: Fifty-one patients underwent LASIK for low myopia and completed questionnaires regarding specific visual symptoms before and after surgery. Each eye was evaluated postoperatively at 1-week, 1-, 3-, 6- and 12-months. Pupils were stratified according to size: small (<5.5mm), medium (5.5 to 6.0mm) and large (>6.0mm). Mesopic pupil size and preoperative and postoperative variables were evaluated using analysis of variance (ANOVA). A regression model was also performed to determine the correlation between mean spherical equivalent and cylinder and visual symptoms.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- no more than 6.00 D of spherical myopia
- no more than 3.00 D of refractive astigmatism
- a stable refraction (less than 0.50D per year of sphere or cylinder)
- a corneal diameter of less than 11.0 mm to allow for suction ring fixation
- discontinuation of soft contact wear at least 7 days prior to preoperative evaluation
- visual acuity correctable to at least 20/20
- age older than 21 years
- ability to participate in follow-up examinations for 12 months after LASIK surgery
Exclusion Criteria:
- use of rigid gas permeable contact lens
- severe dry eye symptoms
- severe blepharitis
- anterior segment abnormalities (i.e. cataracts, corneal scarring, or neovascularization within 1 mm of intended ablation zone)
- recurrent corneal erosion
- severe basement membrane disease
- progressive or unstable myopia or keratoconus
- unstable corneal mires on central keratometry
- corneal thickness in which LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively
- baseline standard manifest refraction of more than 0.75 D in sphere power
- or a difference of greater than 0.50 D in cylinder power compared with baseline standard cycloplegic refraction
- a baseline standard cycloplegic refraction differing more than 0.75 in sphere, 0.50 D in cylinder
- have a different type of astigmatism (i.e. with-the-rule) when the cylinder is greater than 0.50D compared to baseline standard cycloplegic refraction
- preoperative assessment of ocular topography and/or aberrations indicates that either eye is not suitable candidate for LASIK vision correction procedure (i.e. forme fruste keratoconus
- corneal warpage, or pellucid marginal degeneration)
- previous intraocular or corneal surgery
- history of herpes zoster or simplex keratitis
- patients on systemic corticosteroid or immunosuppressive therapy
- immunocompromised subjects or clinically significant atopic disease
- connective tissue disease
- diabetes
- steroid responder
- macular pathology
- pregnant or lactating patients
- patients with sensitivity to planned study concomitant medications
- patients participating in another ophthalmic drug or device clinical trial
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:small
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laser-assisted in situ keratomileusis
其他名称:
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有源比较器:medium
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laser-assisted in situ keratomileusis
其他名称:
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有源比较器:large
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laser-assisted in situ keratomileusis
其他名称:
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合作者和调查者
调查人员
- 副研究员:Annie Chan、Stanford University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LASIK的临床试验
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Walter Reed Army Medical Center完全的
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Bismarck LasikSengi终止
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Moorfields Eye Hospital NHS Foundation Trust完全的