Evaluation of Vitreous Modifications After Cataract Surgery (VitCat)
Assessment of Vitreous Changes Following Cataract Surgery
調査の概要
詳細な説明
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.
Patients will be excluded in the presence of factors that may interfere with accurate vitreous assessment or independently alter vitreoretinal anatomy. These include advanced cataract significantly compromising OCT image quality, pre-existing posterior vitreous detachment, previous vitreous hemorrhage, previous vitreoretinal surgery, prior intravitreal injections, retinal diseases affecting evaluation of the vitreoretinal interface, pathologic high myopia, and a history of ocular trauma or uveitis.
The primary objective is to quantitatively and qualitatively characterize postoperative changes in vitreous morphology and vitreoretinal interface features after cataract surgery. The study is intended to improve understanding of the early structural effects of cataract surgery on the vitreous and to determine whether OCT imaging can reliably document these postoperative modifications.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Paris
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Créteil、Paris、フランス、94000
- 募集
- Centre Hospitalier Intercommunal de Créteil
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コンタクト:
- Marco Pastore, MD, PhD
- 電話番号:+33 (0) 1 57 02 30 54
- メール:marco.pastore@chicreteil.fr
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Presence of cataract scheduled for surgery
- Adequate image acquisition quality
- Absence of posterior vitreous detachment (PVD)
- Availability of both preoperative and postoperative OCT imaging
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
No vitreous detachment
Patients scheduled for cataract surgery without posterior vitreous detachment
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standard cataracte surgery
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration
時間枠:4 weeks
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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.
|
4 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 05072026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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