Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
2022年4月17日 更新者：XiaoYong Liu
We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients.
In this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.
調査の概要
詳細な説明
This study is a clinical case-control study.
A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer.
Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.
研究の種類
観察的
入学 (実際)
36
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
-
-
Guangdong
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Guangzhou、Guangdong、中国、510630
- The First Affiliated Hospital of Jinan University
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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
25年～72年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .
説明
the hemodialysis group Inclusion Criteria:
- Older than 18
- Hemodialysis patient
- The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.
the hemodialysis group Exclusion Criteria:
- Previous history of ocular trauma or surgery
- History of wearing contact lenses
- Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears
- Eyelid abnormalities (such as eyelid insufficiency, entropion and ECTROPION, tumor, severe trichiasis)
- There have been peritoneal dialysis, kidney transplant surgery patients.
the normal group Inclusion Criteria:
- Older than 18
- Healthy people do not have other systemic diseases, such as diabetes and hypertension
- The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.
the normal group Exclusion Criteria:
- Previous history of ocular trauma or surgery
- History of wearing contact lenses
- Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
the hemodialysis group
investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer.
Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.
|
Using ocular surface analyzer for Inspection
|
|
the normal group
investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer.
Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.
|
Using ocular surface analyzer for Inspection
|
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 |
|---|---|---|
|
Non-invasive tear meniscus height
時間枠：1year
|
Maximum and minimum of Non-invasive tear meniscus height in millimetre，higher scores mean a better outcome.
|
1year
|
|
first tear film break-up time
時間枠：1year
|
Maximum and minimum of first tear film break-up time in Seconds，higher scores mean a better outcome.
|
1year
|
|
average tear film break-up time
時間枠：1year
|
Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.
|
1year
|
|
dry eye severity grade
時間枠：1year
|
Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.
|
1year
|
|
tear film lipid layer analysis (distribution and color)
時間枠：1year
|
Maximum and minimum of tear film lipid layer analysis (distribution and color)，higher scores mean a better outcome.
|
1year
|
|
tear film lipid layer thickness grade
時間枠：1year
|
Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.
|
1year
|
|
meibomian gland opening blocking site
時間枠：1year
|
Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland opening blocking analysis
時間枠：1year
|
Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland opening secretion oil character score
時間枠：1year
|
Maximum and minimum of meibomian gland opening secretion oil character score，higher scores mean a worse outcome.
|
1year
|
|
eye redness index analysis (conjunctiva, ciliary shape)
時間枠：1year
|
Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland absence area score
時間枠：1year
|
Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.
|
1year
|
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
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 (実際)
2021年1月1日
一次修了 (実際)
2021年12月31日
研究の完了 (実際)
2021年12月31日
試験登録日
最初に提出
2021年6月26日
QC基準を満たした最初の提出物
2021年6月26日
最初の投稿 (実際)
2021年7月2日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月19日
QC基準を満たした最後の更新が送信されました
2022年4月17日
最終確認日
2022年4月1日
詳しくは
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