Anterior Chamber Versus Retropupillary Iris-claw Intraocular Lens Fixation in Aphakic Children With Insufficient Capsular Support.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Endothelial cell loss
研究概览
简要总结
The Artisan lens (Artisan Aphakic, Ophtec BV) is an iris- claw lens designed for implantation in children with insufficient capsular support. In spite of less surgical manipulations and a relatively shorter operation time, the procedure carries the risk of corneal endothelial cell loss or dis-enclavation, particularly in children. However, most of the studies that studied iris-claw lenses in aphakic children were retrospective evaluated only a single technique; either anterior or retropupillary fixation, or comparable to other techniques of fixation. Thus the aim of this work is to prospectively compare the 2 techniques of iris-claw lens implantation and their effects on central endothelial cell density, the anatomical and visual outcome, as well as the complications' rate.
详细描述
Children for the study will be recruited from the Pediatric Ophthalmology Clinics in Cairo University Hospitals. Children will be included if they have aphakia with insufficient capsular support, hereditary lens subluxation. microspherophakia . or traumatic lens subluxation > 180 degrees that requires lensectomy and intraocular lens implantation .
Patients recruited for this study will be assigned into 2 groups:
- Group A: will have implantation of an anterior chamber iris-claw lens (Ophtec BV, Groningen, The Netherlands)
- Group B: Wil have implantation of a retropupillary iris-claw lens (Ophtec BV, Groningen, The Netherlands)
Preoperative Evaluation
Demographics and History Taking Baseline demographic data will be collected from all patients including
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hereditary lens subluxation that requires lensectomy and intraocular lens implantation.
- •Traumatic lens subluxation that requires lensectomy and intraocular lens implantation.
- •Microspherophakia that requires lensectomy and intraocular lens implantati
- •Aphakia with insufficient capsular support.
排除标准
- •Preoperative central endothelial cell density (CECD) less than 2500 cells/mm2
- •Preoperative anterior chamber depth (ACD) less than 3 mm.
- •Severely damaged iris.
- •History of uveitis or glaucoma.
- •Macular lesions or previous retinal surgery
结局指标
主要结局
Endothelial cell loss
时间窗: 1 year
Percentage of endothelial cell loss from the baseline value
次要结局
- IOL tilt(1 year)
- Best-corrected visual acuity(1 year)
- IOL decentration(1 year)
- Anterior chamber angle(1 year)
- Intraocular pressure(1 year)
研究者
Ahmed Awadein
Professor of Ophthalmology
Cairo University