Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation
研究概览
简要总结
the investigator will evaluate the change in endothelial cell count in eyes implanted with the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular microscopy
详细描述
Iris-fixated phakic intraocular lenses (pIOLs) are used worldwide to correct high myopia, hyperopia, and astigmatism. It is used to correct high degrees of myopia in patients for whom laser excimer refractive surgery is not indicated.
The Artisan lens is designed to minimize the contact between the iris and the IOL resulting in less halo and glare from the prism effect.
Several clinical studies show that the visual results of the Artisan lens are stable and predictable. Artisan phakic IOLs provides precise predictability.
There have been concerns that the anterior chamber lens could damage the endothelial cell layer because of its proximity to the cornea. The manufacturer advises using the Artisan lens only in eyes with an ECD greater than 2000 cells/mm2 and an ACD greater than 2.6 mm.
Corneal endothelium is metabolically active and responsible for keeping the corneal stroma in its usual dehydrated state of 70% water.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age greater than 20 years, stable myopia with a variation in spherical equivalent of less than -0.50 diopter (D) during the 12 month preoperative period, a normal anterior segment with an ACD (i.e., the area between the corneal endothelium and the central anterior lens capsule) greater than 3.00 mm, an endothelial cell count of 2000 cells/mm2 or greater, no corneal, pupil, or iris abnormalities; and no history of glaucoma and chronic or recurrent uveitis , having contraindications to laser in situ keratomileusis based on pachymetric data or other corneal shape characteristics, and an intraocular pressure of 20 mm Hg or less.
排除标准
- •an ACD less than 3.0 mm, history of ocular surgery, glaucoma, chronic uveitis, or preexisting ocular pathologic features or abnormalities.
结局指标
主要结局
Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation
时间窗: 5 minutes
specular microscopy will be performed on a number of myopic patients before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count.
次要结局
未报告次要终点