Dislocated Intraocular Lenses: Effect of Modification of Surgical Repositioning and Capsular Fibrosis Impact on Position of IOL After Fixation Surgery in a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Astigmatism
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. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.
详细描述
In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with in-the-bag dislocated IOL who agree to participate in the study
- •Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery.
排除标准
- •patients with dislocated IOL that is not visible in the pupillary plane
- •IOL design not suitable for suturing using capsular bag
- •patients who are not able to cooperate under measurements
- •patients with Marfan syndrome and ectopia lentis
- •exclusion criterion for the control group: other eye surgery.
结局指标
主要结局
Astigmatism
时间窗: through study completion, an average of 1,5 years
Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively,
IOL position
时间窗: through study completion, an average of 1,5 years
Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
Capsular thickness
时间窗: preoperatively or as soon as possible postoperatively
Measured with OCT and photographed on slit-lamp examination.
次要结局
- Intraocular Pressure (IOP)(through study completion, an average of 1,5 years)
- Number of participants with postoperative complications(through study completion, an average of 1,5 year)
- Best Corrected Visual Acuity (BCVA)(through study completion, an average of 1,5 years)
- administration of IOL lowering therapy(through study completion, an average of 1,5 years)
- inflammation in anterior chamber(through study completion, an average of 1,5 years)
- Precision of the IOL position measurement with OCT(1 month or any other postoperative control through study completion, an average of 1,5 year)
研究者
Laura Armonaite
Principal investigator
St. Erik Eye Hospital