跳至主要内容
临床试验/NCT07143526
NCT07143526尚未招募不适用

Comparison of Two Swept-source Optical Coherence Tomography Angiography (OCTA) Devices (Bmizar and Plexelite) for Detecting Macular Neovascularisation With Large (More Than 250 Microns) Pigment Epithelium Detachment (PED) in Age Related Macular Degeneration

University of Trieste1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices

研究概览

简要总结

The goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients treated for neovascular age related macular degeneration (AMD)
  • Presence of a pigmentary epithelium detachment higher than 250 microns measured on structural optical coherence tomography (OCT)

排除标准

  • Poor image quality or signal strength
  • Undefined retina layers

结局指标

主要结局

Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices

时间窗: Day 1

The optical coherence tomography angiography devices are known to have a difficult time detecting neovascularisation in the cases of large pigment epithelium detachments (PED), because of the many layers and the distance the OCT signal has to cross. The automatic retina segmentation (done by the device of the different retina layers plays a big role in this detection. It's also disturbed by the height of the PED. This study aims to compare the sensitivity of two swept source OCT devices available in the market : Bmizar, Towardpi and Plexelite, Zeiss. After the exam image acquisition, a retina specialist will try to make a manual segmentation of the retina analysed to help the detection of macular neovascularisation that would have been missed in the "normal" automatic segmentation done by the device.

次要结局

未报告次要终点

研究者

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

Marco Rocco Pastore

Department of Ophtalmology Clinical Assistant

University of Trieste

研究点 (1)

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