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治験 NCT06527326（対象：中心性漿液性脈絡網膜症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
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the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy 400
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06527326 は 介入研究 臨床試験 で、中心性漿液性脈絡網膜症 に関するものです。現在は 募集中 で、2024年5月27日 から開始しています。400 名の参加者 の募集が計画されています。この試験は Second Affiliated Hospital, School of Medicine, Zhejiang University によって主導され、2026年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年7月30日 です。
概要
To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), we have observed in our clinical practice that CSC patients often experience chronic gastrointestinal issues. This observation has led us to hypothesize that CSC may be associated with gut dysbiosis. The Bifidobacterium genus is widely recognized as a beneficial gut bacterium, and numerous well-established Bifi...もっと見る
公式タイトル
the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy
疾患名
中心性漿液性脈絡網膜症その他の研究識別子
- 2024-0611
NCT番号
開始日
2024-05-27
最終更新日
2024-07-30
終了予定日
2026-07-01
目標参加者数
400
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
central serous chorioretinopathy
Bifidobacterium genus
the gut dysbiosis
Bifidobacterium genus
the gut dysbiosis
主目的
基礎研究
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的receiving Bifidobacterium supplements | Live Combined Bifidobacterium the Bifidobacterium genus supplement |
プラセボ対照薬receiving placebo | プラセボ Placebo |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Best Corrected Visual Acuity | BCVA is commonly assessed during eye exams to determine the effectiveness of vision correction and to evaluate the impact of eye conditions or diseases on vision. | through study completion, an average of one year |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Central Retinal Thickness (CRT) | Central Retinal Thickness is typically assessed using imaging techniques such as optical coherence tomography (OCT), which provides detailed cross-sectional images of the retina, allowing for accurate measurement of its thickness. | through study completion, an average of one year |
the thickness of Subretinal Fluid (SRF) | Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation. | through study completion, an average of one year |
the thickness of Choroid | Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC). | through study completion, an average of one year |
Choroidal Vascular Index (CVI) | This is a ratio or index that quantifies the proportion of the choroid occupied by blood vessels compared to the total choroidal area. It provides a measure of the relative density of the choroidal vasculature. | through study completion, an average of one year |
Choroidal Vascular Volume (CVV) | This measures the total volume of the choroidal blood vessels within a specific area of the choroid. It reflects the overall blood vessel density and the amount of blood flowing through the choroidal vasculature. | through study completion, an average of one year |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
健康なボランティアを受け入れる
はい
- Age 18 to 60 years
- Diagnosis of acute central serous chorioretinopathy (CSC) (affected eye: ① FFA and ICGA showing typical CSC manifestations, ② presence of subretinal fluid (SRF) at the macular fovea, ③ disease duration ≤ 6 months)
- Best Corrected Visual Acuity (BCVA): 53 to 86 letters
- Other: No significant systemic diseases, signed informed consent, and able to commit to follow-up
- Presence of significant systemic diseases
- BCVA of 20/200 or worse
- Presence of choroidal or retinal atrophy in the macular fovea of the affected eye
- Presence of choroidal neovascularization (CNV), age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), diabetic retinopathy (DR), choroidal hemangioma, pigment epithelial detachment (PED), etc., in the affected eye
- High myopia in the affected eye
Second Affiliated Hospital, School of Medicine, Zhejiang University試験中央連絡先
連絡先: Weixin Zheng, master, +86 18888918935, [email protected]
連絡先: Panpan Ye, doctor, +86 13806506267, [email protected]
1 1カ国の場所
Zhejiang
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hanzhou, Zhejiang, 310000, China
Panpan Ye, doctor, 連絡先, +86 13806506267, [email protected]
Weixin Zheng, master, 連絡先, +86 18888918935, [email protected]
募集中