Distance, Intermediate and Near Visual Outcomes, Range of Vision and Patient Satisfaction After Bilateral Implantation of Different Multifocal IOLs
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery.
研究概览
简要总结
The purpose of this study is to evaluate vision at different distances (far (13 ft), intermediate (2.0 ft) and near (13 to 15 in)) with and without the patient's glasses (if the patient wears them), range of vision (the difference between the farthest distance and the closest distance that the patient can comfortably read 20/25 of the near card), and patient satisfaction (how satisfied/happy is the patient with their vision) following bilateral implantation of different multifocal IOLs after routine phacoemulsification.
The patients are being asked to participate in this study because you have had cataract surgery and have received one of the IOLs implanted: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, and/or ReZoom. The investigator in charge of this study is Dr. Helga Sandoval. This study is being conducted at Storm Eye Institute at the Medical University of South Carolina and will involve approximately 50 volunteers.
详细描述
STUDY DESIGN:
This is a prospective, non-randomized, unmasked pilot study.
- SETTING:
Storm Eye Institute, Medical University of South Carolina, Charleston, SC 2. SUBJECTS
A total of 50 patients of both sexes and any race or ethnic background who underwent uneventful routine bilateral cataract extraction and multifocal or accommodating intraocular lens implantation will be included. Subjects will be divided in 5 groups of 10 subjects each based on the IOL implanted as follows: ReSTOR +4.0 D, ReSTOR +3.0 D, Crystalens, ReZoom, and Mix-and-match (patients implanted with ReSTOR in one eye and ReZoom in the fellow eye).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
- •Subject must have a multifocal or an accommodating IOL implanted bilaterally.
- •Age: 40 to 90 years old.
- •At least 3 months after cataract extraction and intraocular lens implantation in the second eye.
- •Willing and able to comply with scheduled visit and other study procedures.
排除标准
- •Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- •Ocular pathology affecting visual acuity: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration (with best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- •Keratometric astigmatism exceeding 2.00 diopters.
- •Planned postoperative refraction for mono-vision.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- •Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- •Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in either eye.
- •Other ocular surgery at the time of the cataract extraction.
结局指标
主要结局
To evaluate visual outcomes at distance, intermediate and near as well as range of vision and patient satisfaction after bilateral implantation of multifocal or accommodating IOLs post routine cataract extraction at least 3 months after surgery.
时间窗: six months
次要结局
未报告次要终点