Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Satisfaction
研究概览
简要总结
This study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey.
详细描述
Purpose: To compare patient-reported satisfaction with a multifocal vs an accommodating presbyopia-correcting at least two years following implantation of either type of implant.
Number of study subjects: 200 (half with multifocal and half with accommodating lens implants)
In this study, we will send a secure, online questionnaire to patients who have previously undergone cataract surgery at least two years previously. Patients will receive an email invitation, and by clicking the embedded link and verifying their identity with date of birth and phone number, they will be directed to a survey. The survey will ask the following types of questions:
- overall satisfaction with the surgery
- would they do the same surgery again?
- would they choose the same (elective) lens implant again?
- for what types of activities (reading newspaper, driving, driving at night, fine print) do they require glasses to see clearly?
- do they experience glare and halo symptoms?
- how bothered is the patient by these symptoms?
These data will be stored on a secure server. Statistical analysis will be done by a statistician, using a student's t-test to determine statistical significance of any difference between patients with different types of lens implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously
- •Patients with or without astigmatic keratotomy or other simultaneous procedures may be included, so long as exclusion criteria are not met.
排除标准
- •Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that, in the best judgment of the investigator, could affect their satisfaction with surgery
- •Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
- •Patients with ≥ grade 1 posterior capsule opacity at their last visit
结局指标
主要结局
Satisfaction
时间窗: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
The patients will be asked to rate their satisfaction with their surgical results on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".
次要结局
- Ability to drive without glasses(At least 24 months after cataract surgery was performed. No upper limit on time since surgery.)