Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Postoperative Complications
研究概览
简要总结
A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.
详细描述
In this prospective, randomized study The investigators will include at least 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.
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
盲法说明
Investigator masked for group affiliation during image analysis
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with dislocation of IOL in the capsular complex who agree to participate in the study
排除标准
- •patients with total dislocation of the capsular complex'
- •patients with reduced general health
- •patients who can't be randomized
研究组 & 干预措施
IOL repositioning
Operation method: Intraocular lens repositioning by scleral suturing
干预措施: Intraocular lens repositioning by scleral suturing (Procedure)
IOL exchange
Operation method: Intraocular lens exchange with retropupillary iris-claw lens
干预措施: Intraocular lens exchange with retropupillary iris-claw lens (Procedure)
结局指标
主要结局
Postoperative Complications
时间窗: 6 months and 2 years
Cystoid macular edema considered the most important long-term complication and therefore reported here.
Best Corrected Visual Acuity (BCVA)
时间窗: 6 months, 1 year and 2 years
Measure for visual function. Measured in logMAR
Intraocular Pressure (IOP)
时间窗: 6 months and 2 years
Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
Endothelial Density
时间窗: 6 months
Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter
次要结局
- Keratometry(6 months (only analyzed/reported for this time frame))
- Questionnaire Visual Function-14 (VF-14) Score(6 months (only analyzed/reported for this time frame))
- IOL Location(2 years)
研究者
Marius Dalby
MSc
Oslo University Hospital