Endothelial Cell Loss and Surgically Induced Astigmatism After 2.2 mm Wound Assisted vs 2.4 mm Wound-Directed Clear Corneal Incisions for Intraocular Lens Insertion During Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Surgically induced astigmatism
研究概览
简要总结
The purpose of this study is to determine if there is any difference in astigmatism (eye surface curvature) or corneal endothelial cell density (the inner cell lining of the eye surface) after two different methods for inserting a lens during cataract surgery.
详细描述
Cataract surgery (removal of a cloudy lens) is currently performed through increasingly smaller incisions. Bimanual surgery, where two instruments are used to remove the lens, is performed through two 1.4 mm incisions. Typically, one of these incisions is enlarged to 2.2 or 2.4 mm in order that the IOL (artificial lens) can be inserted into the eye. Surgeons insert these lenses by placing a lens injector cartridge completely into the eye (wound-directed insertion) or by placing only the tip inside the incision (wound-assisted insertion). While wound-assisted insertion can be performed through slightly smaller incisions (2.2 mm versus 2.4 mm for wound-directed insertion), both methods of insertion cause some incision enlargement. There is some evidence that wound-assisted insertion can cause very short-term pressure within the eye to go up. Neither method is considered inferior or superior to the other, and the primary investigator (Dr. Kenneth Cohen) routinely uses both methods.
No studies have directly compared wound-healing characteristics between these two methods. We seek to compare differences in:
- Surgically-induced astigmatism (changes in the corneal curvature from cataract surgery incisions.
- Endothelial cell density loss. Endothelial cells line the inside surface of the cornea, and their overall density can be decreased by cataract surgery.
- Best-corrected vision after surgery
- Sizes of the incisions after lens injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Eligible patients include those who undergo uncomplicated cataract extraction surgery and IOL implantation by KLC.
排除标准
- •Patients who:
- •suffer from diabetes and have more than mild background diabetic retinopathy,
- •have a history of intraocular surgery,
- •have a history of ocular trauma,
- •have known pathology of the cornea,
- •have a history of intraocular inflammation,
- •are unable to understand English,
- •are decisionally impaired,
- •are currently incarcerated, or
- •are less than 18 years of age.
- •No exclusions will be made on the basis of gender, ethnicity, or race.
结局指标
主要结局
Surgically induced astigmatism
时间窗: 1 month
measured by topography at 1 month post operative visit
次要结局
- Endothelial cell loss(one month)
- Best corrected visual acuity(one month)
- Final incision size(intraoperatively (day #0))