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临床试验/NCT06731530
NCT06731530招募中不适用

A Comparative Study of Anterior Segment Structural Features, Biomechanical Behaviour and Optical Properties of the Cornea in Patients With and Without Pseudoexfoliation Syndrome.

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
86
试验地点
1
主要终点
Corneal optical density assessed by backscatter measurement

研究概览

简要总结

The purpose of this study is to assess the effect of pseudoexfoliation syndrome on corneal biomechanics, optical clarity of the cornea, and anterior segment structural features.

详细描述

A case group of patients with pseudoexfoliation syndrome will ungergo examinations to evaluate corneal optical properties (Pentacam-AXL, HD analyzer), biomechanics (Corvis ST) and anterior segment structural features (OCT-A Angiovue, Pentacam-AXL, IOLMaster V.5.4, Topcon SP-1P). The same examinations will be performed on a group of age-matched controls, and the results will be compared.

Corneal optical density will be assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany).

Corneal optical density will also be assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler). The level of agreement between the two optical density indicators (OSI, COD) will be evaluated.

Corneal biomechanics measurements will be performed using Corvis Scheimpflug Technology. The main biomechanical parameter of the Corvis ST is DA (deformation amplitude). DA quantifies how the cornea deforms in response to an air puff and helps evaluate corneal stiffness and elasticity.

An additional objective is the study of structural parameters of the cornea as well as, more broadly, the anterior segment in pseudoexfoliation syndrome (PEX) patients, aiming to understand and describe the effects of PEX with the highest possible accuracy. Specifically, using the Pentacam-AXL (Oculus, Wetzlar, Germany), the IOLMaster V.5.4 (Carl Zeiss Meditec), the OCT-Angiography Angiovue (Optovue, Inc., Fremont, California, USA), and the specular microscope Topcon SP-1P (Topcon Medical Inc., Tokyo, Japan), a comparative study will be conducted across a range of variables and maps: corneal topographic data, keratometric measurements, curvature radius data, pachymetric data, anterior chamber depth and volume, angle width, axial length, pupil diameter, and endothelial cell density. Some of these data, such as central corneal thickness, can be measured by two of the aforementioned devices. In this case, we will also attempt to evaluate the level of agreement between the two devices.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 60-80 years.
  • unilateral or bilateral pseudophakia (cataract surgery undergone at Papageorgiou General Hospital, Thessaloniki, Greece).
  • open anterior chamber angle (grade > 2, van Herick method).

排除标准

  • History of intraocular surgery other than uncomplicated cataract surgery (phakoemulsification).
  • Cataract surgery within the last 3 months.
  • History of ocular trauma.
  • Use of contact lenses.
  • Corneal pathology.
  • Use of anti-VEGF medications.
  • History of uveitis or active uveitis.
  • Hypertension (IOP > 21 mmHg) or glaucoma.
  • Myopia or hyperopia greater than 3 diopters.
  • Astigmatism greater than 1.5 diopters.
  • Posterior capsular opacification grade 2, 3, or 4 based on the EPCO grading scale.
  • Tear break-up time <10 sec

结局指标

主要结局

Corneal optical density assessed by backscatter measurement

时间窗: Baseline, during examination : approx. 1 hour

Corneal optical density assessed by backscatter measurement (COD, corneal optical density) using Pentacam AXL (Oculus, Wetzlar, Germany)

Corneal optical density assessed by forward-scatter measurement

时间窗: Baseline, during examination : approx. 1 hour

Corneal optical density assessed by forward-scatter measurement (OSI, objective scatter index) using HD Analyzer (Visiometrics, Terassa, Spain, Keeler)

次要结局

  • Corneal biomechanics using Corvis Scheimpflug Technology(Baseline, during examination : approx. 1 hour)
  • Optical quality measured by HD-analyzer : Strehl ratio(Baseline, during examination : approx. 1 hour)
  • Optical quality measured by HD-analyzer : MTF cut-off(Baseline, during examination : approx. 1 hour)
  • Corneal biomechanics using Corvis Scheimpflug Technology : velocity(Baseline, during examination : approx. 1 hour)
  • Corneal biomechanics using Corvis Scheimpflug Technology : length(Baseline, during examination : approx. 1 hour)
  • Corneal biomechanics using Corvis Scheimpflug Technology : bIOP(Baseline, during examination : approx. 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolaos Ziakas

Professor of Ophthalmology

Aristotle University Of Thessaloniki

研究点 (1)

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