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临床试验/NCT07816887
NCT07816887招募中不适用

Assessment of Vitreous Changes Following Cataract Surgery

University of Trieste1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration

研究概览

简要总结

This study aims to evaluate changes in vitreous structure and the vitreoretinal interface following cataract surgery using spectral-domain optical coherence tomography (OCT). Patients undergoing cataract surgery will undergo standardized OCT imaging before and after surgery. Preoperative and postoperative images will be compared to identify and characterize qualitative and quantitative changes in vitreous morphology, with particular attention to the posterior vitreous and its relationship with the retinal surface.

详细描述

Cataract surgery may induce anatomical and biomechanical changes within the vitreous body and at the vitreoretinal interface. However, the extent and characteristics of these modifications remain incompletely defined, particularly when assessed using high-resolution optical coherence tomography (OCT).

The aim of this study is to investigate structural changes in the vitreous and vitreoretinal interface occurring after cataract surgery through a standardized preoperative and postoperative spectral-domain OCT imaging protocol.

Patients with cataract scheduled for surgery will be considered for inclusion. Eligible participants must have OCT images of sufficient quality for reliable assessment and no evidence of posterior vitreous detachment (PVD) at baseline. Both preoperative and postoperative OCT imaging must be available for comparative analysis.

Standardized OCT acquisition will include the 18 Line R64 and AS Star 18 Line R16 imaging protocols using the Dream OCT platform. These scans will be used to assess the posterior vitreous, its relationship with the retinal surface, and any postoperative changes in vitreous morphology or vitreoretinal interface configuration.

Preoperative and postoperative images will be compared both qualitatively and quantitatively. The analysis will focus on identifying changes in the visibility, configuration, position, and attachment of the posterior vitreous structures, as well as any modifications of the vitreoretinal interface occurring following cataract surgery.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of cataract scheduled for surgery
  • Adequate image acquisition quality
  • Absence of posterior vitreous detachment (PVD)
  • Availability of both preoperative and postoperative OCT imaging

排除标准

  • Advanced cataract significantly compromising image quality
  • Presence of posterior vitreous detachment (PVD)
  • History of vitreous hemorrhage
  • Previous vitreoretinal surgery
  • Previous intravitreal injections (IVT)
  • Retinal diseases affecting vitreoretinal interface assessment
  • Pathologic high myopia
  • History of ocular trauma or uveitis

研究组 & 干预措施

No vitreous detachment

Patients scheduled for cataract surgery without posterior vitreous detachment

干预措施: cataract surgery (Procedure)

结局指标

主要结局

Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration

时间窗: 4 weeks

Preoperative and postoperative OCT images will be compared to identify participants showing structural changes in the posterior vitreous or vitreoretinal interface, including changes in posterior hyaloid position, vitreoretinal attachment status, and the development of partial or complete posterior vitreous detachment (PVD). Results will be reported as the number and proportion of participants presenting these postoperative changes.

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

MD, PhD

Centre Hospitalier Intercommunal Creteil

研究点 (1)

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