To Assess if Using a High Resolution Immersion Ultrasound Measurement Improves Intraocular Lens Power Calculation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Difference in mean absolute error in refractive outcome
研究概览
简要总结
Assess is the additional use of high resolution immersion ultrasound measurements improve the refractive outcome after cataract surgery.
详细描述
Since the beginning of biometry, immersion ultrasound was shown to be accurate and reproducible. It is important to distinguish between immersion ultrasound techniques and contact ultrasound. The later was shown to be less accurate and examiner dependent.
Although immersion ultrasound has been improved significantly and novel high resolution ultrasound devices are available, the drawback of this technique is that measurement s take longer compared to optical biometry. The advantage of immersion ultrasound is that structures behind the iris are visible, whereas in optical biometry only structures within the pupil are visible.
Immersion ultrasound as well optical biometry can be used to calculate the needed power of an intraocular lens (IOL) to achieve the aimed post-operative refraction. Although IOL power calculation improved within the last decades, refractive surprises occur, especially in cases with very short eyes.
The estimation of the post-operative IOL position and therefore the estimated anterior chamber depth (ACD) is presently the main source of error (35% to 42%) in IOL power calculation and therefore for the refractive outcome of the patients after cataract surgery. Early IOL power calculation formulae, such as the Binkhorst I formula, used a fixed ACD value to predict the position of the IOL, but the refractive results were not appropriate because the post-operative position of the IOL varied significantly between patients. Later observations showed a correlation between the axial eye length and the post-operative ACD (more myopic eyes showed a larger ACD post-operatively). These correlations were taken into account in later developed formulas (such as the Binkhorst II formula). Olsen et al. measured the post-operative ACD and substituted the predicted post-operative ACD with the true, post-operative ACD in each case. The result after correcting the IOL position was a highly accurate IOL power calculation, where no fudge factors were needed. Presently the pre-operatively measured ACD is taken into account for several IOL power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen formula. However, this new generation of formulas use the pre-operative ACD, without considering the thickness of the crystalline lens. The ACD is measured as the distance between the anterior surface of the cornea (anatomically speaking this should be the posterior surface of the cornea, but in an optical context, as in IOL power calculations, the anterior surface is used) and the anterior surface of the crystalline lens . Therefore the thickness of the crystalline lens has a significant impact on the predicted post-operative position of the IOL. This parameter was first taken into account by Olsen and later modified by Norrby.
It should be mentioned that IOL power calculations developed from theoretical calculations based on Gaussian optics to regression formulas, such as the SRK formula that uses retrospective data of a large number of patients. All these findings suggest that proper measurements not only of the dimensions of the crystalline lens but also of the lens capsule after removing the crystalline lens are necessary to improve IOL power calculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 21 and older
- •Able to understand the patient information
- •Willing to follow the instructions and attend all follow-up visits
- •Willing to sign informed consent prior to surgery
排除标准
- •Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
- •Previous ocular surgeries on the study eye
- •Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
- •Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)
结局指标
主要结局
Difference in mean absolute error in refractive outcome
时间窗: 12 months
The difference in refractive error will be measured using auto- and subjective refraction
次要结局
- Anterior chamber depth and lens thickness measurement(12 months)
- IOL tilt and decentration(12 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery
