Evaluation of the Long-term Efficacy and Safety of Monofocal Plate Haptic Intraocular Lens to be Implanted Into the Eye in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
Our study aims to determine the efficacy and safety of the monofocal plate haptic intraocular lens to be implanted in patients planning for cataract surgery and to determine the complications that may develop due to the lens.
详细描述
This study was planned to be performed on 300 eyes with surgical indication due to cataracts in Van Yüzüncü Yıl University Faculty of Medicine Ophthalmology Outpatient Clinic. Uncorrected and best-corrected visual acuity, subjective refraction, slit-light biomicroscopy, optical biometry, anterior segment optical coherence tomography, intraocular pressure, endothelial cell count in the pre-and postoperative (1st, 3rd, and 12th months) controls of the patients. Fundus examination will be performed, and postoperative complications and accompanying ocular pathologies will be recorded. Data before and after surgery effectiveness will be evaluated. Reliability will be interpreted by considering postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- •Patients of any gender
- •Assured follow-up examinations
- •Biometry measurement preferably compatible with the Lenstar evaluation;
- •IOL implanted into the capsular bag with IOL model Acriva BB UDM 611 (UVE material) in one or both eyes
排除标准
- •BCVA not available preoperatively or better than 0.3 logMAR pre-op
- •Patients unable to meet the limitations of the protocol or likely to non-cooperation during the trial
- •Patients with peroperative complications (Such as capsulorhexis problems that affect centralization, failure of the IOL implanting into the bag, posterior capsular rupture, iris damage, vitreous loss, IOL damage, etc.)
结局指标
主要结局
Visual acuity
时间窗: 12 to 18 months after surgery
Monocular best corrected distance visual acuity
次要结局
未报告次要终点
研究者
Erbil Seven
MD, Associate Professor
Yuzuncu Yıl University