跳至主要内容
临床试验/NCT07297849
NCT07297849招募中不适用

The Effect of Eyelid Closure on the Quality Index of Keratometric Measurements: a Non-controlled Interventional Study

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
29
试验地点
2
主要终点
Difference in discordant pairs of keratometry quality warnings between the first and third measurement

研究概览

简要总结

Cataract surgery is one of the most common performed surgeries in the world. While in the early beginnings of cataract surgery, visual rehabilitation was the main goal of the procedure, refractive outcome and subsequent relative spectacles independency is gaining increasing importance in patients' demands. Due to the improvements in measurement techniques and prediction formulas, the prediction of postoperative refraction is possible with high accuracy. However, there are still some sources of error that lead to deviations of predicted postoperative refraction. For instance, it was shown that tear film osmolarity, an established biomarker for dry eye disease (DED), plays an important role in preoperative precision of keratometry measurements. Keratometry, the measurement of corneal curvature, is an important part of preoperative biometry. Errors in preoperative keratometry measurements lead to nearly one-to-one deviations from the predicted refraction. Therefore, proper keratometry measurements are a key element in intraocular lens (IOL) power calculations. To counteract the issue of DED in preoperative biometry, the principle of using lubricating eye drops before ocular biometry has been investigated and it was shown that the use of ocular lubricants may lead to increased variability of keratometry measurements. From our clinical observations, another possible mechanism to improve keratometry is eyelid closure for some minutes. In contrast to the long-term use of ocular lubricants to stabilize the tear film, eyelid closure is an easy and fast intervention to possibly improve the precision of keratometry measurements. Additionally, a clinical trial investigating the usage of lubricating eye drops for two weeks found no improvement of variability of keratometry in DED patients.

Therefore, this study aims to investigate the effect of eyelid closure on the quality index of keratometric measurements in patients with a warning for the quality of keratometric measurements. For this purpose, a single study day including 4 repeated measurements (2 without and 2 with lid closure for 3 minutes) using an ocular biometer (IOLMaster700) will be performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Written informed consent
  • Keratometry quality index "warning"

排除标准

  • Severe corneal conditions that may compromise corneal integrity (such as corneal scarring, etc.)
  • Pregnancy (pregnancy test will be taken in women of reproductive age), nursing women
  • Ocular surgery in the study eye in the three months preceding the study
  • Inability of visual fixation (e.g. in patients with nystagmus)
  • Inability of eyelid closure (e.g. in patients with facial nerve paralysis)

结局指标

主要结局

Difference in discordant pairs of keratometry quality warnings between the first and third measurement

时间窗: Baseline measurement (time: 0 minutes) to third study measurement (time: approximately after 6 minutes - after 3 minutes of eyelid closure) at the same study day

As the outcome is binary (successful measurement vs. measurement with a warning/failed), the difference in discordant pairs of keratometry quality warnings between the first and third measurement

次要结局

未报告次要终点

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Head of Department

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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