Effect of Preoperative Pupil Size on Quality of Vision After Wavefront-Guided LASIK
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate whether the size of the pupil has an effect on quality of vision in patients undergoing LASIK surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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