Impact of Capsular Tension Ring Implantation on Intraocular Lens Tilt and Decentration in Cataract Patients With High Myopia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- IOL dencentration
研究概览
简要总结
This is a randomized controlled trial to investigate the effect of capsular tension ring (CTR) implantation on intraocular lens (IOL) tilt and decentration in cataract patients with high myopia.
详细描述
Exact positioning and alignment of the IOL with the visual axis are the prerequisites of high-quality visual performance after cataract surgery. A certain degree of IOL tilt and decentration occur after uneventful cataract surgery, most of which are clinically tolerant. However, the relatively large capsular bag volume, zonular weakness, and vitreous liquefaction in cataract patients with high myopia may increase the IOL position instability, such as tilt, decentration and even dislocation, leading to the deterioration of visual function. Thus, how to improve the long-term stability of IOL position in high myopic cataract patients is an urgent issue to be addressed.
Previous studies have shown that CTR implantation during cataract surgery can increase the IOL stability in patients with normal axial length; however, its impact on IOL position of cataract patients with high myopia remains unclear.
In this randomized clinical trial, patients who meet the inclusion criteria will be divided into three layers according to the axial length:
(1)26mm≤AL<28mm (2)28mm≤AL<30mm (3)AL≥30mm
We are going to recruit 186 patients in total, with 62 patients in each layer. Patients on each layer will be randomly divided into experimental group (CTR implantation) and control group (only IOL implantation). If both eyes of a patient meet the inclusion criteria, only the first operated eye is included in the statistics analysis.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old;
- •axis length≥26mm;
- •Visually significant cataract;
- •The patient is willing and able to complete all necessary follow-ups and examinations.
排除标准
- •Intraoperative or postoperative complications: such as intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, endophthalmitis, etc.;
- •Other ocular comorbidity: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;
- •History of intraocular surgery;
- •Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;
- •Any condition that the study physician considers to be an impediment to the clinical trial.
结局指标
主要结局
IOL dencentration
时间窗: 3 months after surgery
Measured by anterior segment OCT (CASIA2)
次要结局
- Visual function(3 months, 6 months, 1 year after surgery)
- IOL dencentration(Baseline (before surgery), 1 week, 1 month, 6 months, 1 year after surgery)
- IOL tilt(Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- Posterior capsule attachment with IOL(1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- Posterior capsular opacification(1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- Optical quality(Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- Anterior capsule contraction(Baseline, 1 week, 1 month, 3 months, 6 months, 1 year after surgery)
- BCVA(Baseline (before surgery), 1 week, 1 month, 3 months, 6 months, 1 year after surgery)
研究者
Xuhua Tan
Associate Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University