Protein Profile of Immunoregulatory Factors in Diabetic Cataract
2013年4月10日 更新者：Danka Grcevic、University of Zagreb
The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.
調査の概要
詳細な説明
The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.
Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.
Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.
研究の種類
介入
入学 (実際)
61
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Brodsko-posavska zupanija
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Slavonski brod、Brodsko-posavska zupanija、クロアチア、35000
- Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
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Grad Zagreb
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Zagreb、Grad Zagreb、クロアチア、10000
- Department of Physiology and Immunology, University of Zagreb School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- patients undergoing phacoemulsification combined with IOL implantation
- for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
- for diabetic group: therapy with oral hypoglycemic agents for glycemic control
- no other ocular (retinal) or systemic diabetic complications of T2DM
Exclusion Criteria:
- patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
- patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：senile cataract with NSAID
15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. |
Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.
他の名前：
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実験的：diabetic cataract with NSAID
17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac. |
Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.
他の名前：
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介入なし：senile cataract without NSAID
17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
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介入なし：diabetic cataract without NSAID
12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac. |
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 |
時間枠 |
|---|---|
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serum level of interleukin-10
時間枠：2 hours before the surgery
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2 hours before the surgery
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serum level of monocyte chemotactic protein-1
時間枠：2 hours before the surgery
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2 hours before the surgery
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serum level of interleukin-17
時間枠：2 hours before the surgery
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2 hours before the surgery
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serum level of Fas ligand
時間枠：2 hours before the surgery
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2 hours before the surgery
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serum level of vascular endothelial growth factor
時間枠：2 hours before the surgery
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2 hours before the surgery
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level of interleukin-10 in aqueous humor
時間枠：intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of monocyte chemotactic protein-1 in aqueous humor
時間枠：intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of interleukin-17 in aqueous humor
時間枠：intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of Fas ligand in aqueous humor
時間枠：intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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level of vascular endothelial growth factor in aqueous humor
時間枠：intraoperatively, at the start of the surgical procedure
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intraoperatively, at the start of the surgical procedure
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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degree of corneal edema
時間枠：preoperatively - 2 hours before the surgery
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preoperatively - 2 hours before the surgery
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degree of corneal edema
時間枠：postoperatively - day 1
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postoperatively - day 1
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degree of corneal edema
時間枠：postoperatively - day 8
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postoperatively - day 8
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degree of corneal edema
時間枠：postoperatively - week 3
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postoperatively - week 3
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degree of corneal edema
時間枠：postoperatively - month 3
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postoperatively - month 3
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Danka Grcevic, prof.,MD,PhD、University of Zagreb
- 主任研究者：Sanja Mitrovic, MD、Department of Ophthalmology, General Hospital "Dr. J. Bencevic"
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2013年4月5日
QC基準を満たした最初の提出物
2013年4月10日
最初の投稿 (見積もり)
2013年4月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年4月16日
QC基準を満たした最後の更新が送信されました
2013年4月10日
最終確認日
2013年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。