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临床试验/NCT07425626
NCT07425626进行中(未招募)不适用

Pilot Evaluation of Cataractous Lens Stiffening Using a Brillouin Scanning Device

Prim. Prof. Dr. Oliver Findl, MBA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Brillouin shift/stiffness metrics

研究概览

简要总结

To provide first results for biomechanical properties of cataractous lenses via Brillouin microscopy and correlations between LOCS III grading, cataractous lens scans from optical coherence tomography (OCT), and intraoperative phacoemulsification energy.

详细描述

Brillouin microscopy (BM), based on Brillouin light scattering theory, has become established in clinical ophthalmology for examining retinal properties, corneal diseases, and age-related lens changes. These BM-derived metrics can portray the intrinsic characteristics of the biosystem, such as the hydration state or the content and anisotropy of corneal collagen fibers, while remaining unaffected by factors such as intraocular pressure and central corneal thickness. In vivo, BM has been shown to characterize the depth-dependent or gradient viscoelastic properties of ocular lenses. Some studies have used this technique to show that the lens nucleus thickens with age, while the thickness of the lens cortex remains constant. Laboratory studies have also shown an increase in the stiffness of the lens nucleus, while later clinical Brillouin measurement studies have shown that the nucleus is clearly distinct from the softer cortex.

Although data on age-related lenticular changes already exist, the in vivo lenticular biomechanics of cataract lenses derived from Brillouin still need to be comprehensively investigated. This is relevant in that the correlation of Brillouin-derived cataract lens mechanics with the Lens Opacity Classification System (LOCS III) and/or the phacoemulsification energy required for cataract surgery may provide useful information about whether the technique could provide valuable insights into lens nuclear stiffening. Very hard or soft nuclei remain one of the major risk factors for the complications occuring during cataract surgery. In the former case, a significantly higher amount of energy is required during phacoemulsification, which can lead to simultaneous damage to the corneal endothelium and prolonged surgical recovery. In the latter case, intraoperative fragmentation of the cell nucleus poses a challenge.

Currently, the type, degree, and (representative) hardness of the cataract lens are assessed preoperatively using a slit lamp examination with the LOCS III system. The degree of lens opacity provides information about how phacoemulsification should be performed, which viscoelastic device should be selected, and what experience the surgeon needs to perform the operation. However, the slit lamp assessment method is susceptible to subjective variability between observers. Given the unique characteristics of assessing the biomechanical properties of the lens in vivo and the short scan time, BM could be used as a novel complementary objective method for surgical decision-making.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Men and women aged above 21 years
  • Normal ophthalmic findings except previous surgery or conditions that impact corneal optical quality such as trauma and corneal scars
  • Willing to sign informed consent before measurements
  • Presence of nuclear cataract according to LOCS III grading and planned cataract surgery

排除标准

  • Any of the following will exclude a subject from the study:
  • Patients with inadequate corneal imaging or corneal scarring that would impact results
  • Patients with active ocular infections or inflammatory conditions
  • Patients that suffered an eye trauma according to their medical history
  • Patients with fixational problems (e.g., nystagmus) or with any medical condition that could interfere with the measurements
  • Pregnancy (pregnancy test will be performed in women of reproductive age)

研究组 & 干预措施

Cataract Patients

50 Patients with Cataract

干预措施: Brillouin-Microscopy (Device)

结局指标

主要结局

Brillouin shift/stiffness metrics

时间窗: 24 months

Correlation between Brillouin shift/stiffness metrics and LOCS III grading, OCT lens opacification scans/metrics and and intraoperative phacoemulsification energy

次要结局

  • Repeatability of Brillouin-Microscopy Measurements(24 months)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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