Capsular Bag Performance of Two Hydrophobic Intraocular Lenses of Different Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Anterior chamber depth
研究概览
简要总结
Comparison of the capsular bag performance of two hydrophobic intraocular lenses of different design.
详细描述
Continuous improvements in cataract surgery technique, intraocular lens (IOL) materials, and design over the past few decades, have led to a more safe procedure with satisfactory refractive outcomes and a short rehabilitation time. By that, patients' expectations concerning their postoperative visual quality and refractive outcome are increasing. However, two main problems might occur after cataract surgery: instability of the IOL position in the capsular bag and formation of posterior capsule opacification (PCO). Both may decrease the optical performance of an IOL.
The performance of an IOL depends on its behaviour in the capsular bag, which has an influence on the anterior chamber depth (ACD), as well as the postoperative refractive shift, the tilt and decentration of the IOL. Several factors such as IOL design and material, capsulorhexis size, capsular bag diameter, and capsular fibrosis or shrinkage may lead to a suboptimal IOL position. Misalignment of an IOL away from the retina leads to a myopic shift, while towards the retina leads to a hyperopic outcome. This explains why inaccurate prediction of postoperative ACD remains the main source of error in IOL power calculation.
One main goal of modern cataract surgery is to yield a low and predictable ACD shift as well as low degrees of IOL tilt and decentration after surgery in order to achieve ideal optical performance of the IOL.
Another aspect of capsular bag performance of an IOL is posterior capsule opacification (PCO). PCO is one of the most frequent long-term complications after cataract surgery leading to dissatisfying results by decreased visual function. Source of PCO are lens epithelial cells from the equator of the lens capsule, which acquire the ability to migrate and proliferate, causing epithelial ingrowth between the IOL and the posterior capsule. It is estimated that PCO occurs at a rate of 12% one year, 21% three years, and 28% five years after cataract surgery. PCO can be treated with neodymium-doped yttrium aluminium garnet (Nd:YAG) laser capsulotomy. However, complications including an increase in intraocular pressure, ocular inflammation, cystoid macular edema, and retinal detachment may occur after this treatment. Hence lower rates of PCO would improve patients long term safety following cataract surgery. Moreover, it would increase patient satisfaction.
The material and design of an IOL may have an effect on the formation of PCO. Sharp optic edge design has been shown to be a major factor in the prevention of PCO. Furthermore, acrylic and silicone hydrophobic materials showed a lower risk for PCO formation and lower rates of postoperative Nd:YAG laser capsulotomy than hydrophilic IOLs.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 105 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related bilateral cataract
- •Age 21 or older
- •Visual acuity > 0.05
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Written informed consent prior to surgery
排除标准
- •Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), traumatic cataract, intraoperative Floppy Iris Syndrome (IFIS), or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)
- •Any ophthalmic comorbidity that may compromise visual function or create problems with measurements (e.g. macular degeneration, amblyopia, corneal scars, etc.)
- •Previous ocular surgery or trauma
- •Pregnancy (pregnancy test will be taken in women of reproductive age)
结局指标
主要结局
Anterior chamber depth
时间窗: 24 months
Anterior chamber depth will be assessed using a biometry device and will be compared between both monofocal IOLs
次要结局
- IOL tilt(24 months)
- Posterior capsule opacification (PCO)(24 months)
- Visual acuity(24 months)
- Catquest 9SF questionnaire(24 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery
