Impact of IOL Glistenings on Visual Quality and Function in Patients Implanted With a Single-Piece AcrySof IOL That Exhibits Glistening Formation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Light scattering
研究概览
简要总结
This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of obvious glistenings by slit lamp exam
- •Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam
排除标准
- •Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
- •Any documented glaucoma of any kind.
- •Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
- •Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
- •Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
- •Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
- •Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
- •Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.
- •Any contraindication to pupil dilation
结局指标
主要结局
Light scattering
时间窗: Post-opertative
Correlation of random light scattering (measured with the C-Quant device) with severity of glistenings in the lenses
次要结局
- Visual function(Post-operative)
- Visual quality(Post-operative)