A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)
2015年11月2日 更新者:Allergan
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery.
No treatment is administered in this study.
調査の概要
研究の種類
観察的
入学 (実際)
204
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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Manitoba
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Brandon、Manitoba、カナダ
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Nova Scotia
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Halifax、Nova Scotia、カナダ
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Ontario
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Barrie、Ontario、カナダ
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Ottawa、Ontario、カナダ
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Toronto、Ontario、カナダ
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Quebec
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Boisbriand、Quebec、カナダ
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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
50年歳以上 (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
サンプリング方法
非確率サンプル
調査対象母集団
Patients with planned cataract removal surgery
説明
Inclusion Criteria:
- Scheduled to undergo cataract removal surgery
Exclusion Criteria:
- Current use of eye drops or oral medications for allergic conjunctivitis
- Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
- Use of a contact lens within 4 weeks
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 |
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Patients with Planned Cataract Removal
Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease.
No treatment is administered.
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介入なし
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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 |
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Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
時間枠:Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
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Up to 60 Days Prior to Surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining.
The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination.
Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe.
Higher values represent a worse outcome.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs.
The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire.
The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms
時間枠:Up to 60 days prior to cataract surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire.
The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
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Up to 60 days prior to cataract surgery
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Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears
時間枠:Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Artificial Tear usage was assessed by the investigator.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 With Punctal Plugs
時間枠:Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
A history of punctual plug usage was assessed by the investigator.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2
時間枠:Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination.
Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe.
Higher values represent a worse outcome.
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Up to 60 Days Prior to Surgery
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Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32
時間枠:Up to 60 Days Prior to Surgery
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Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye.
Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100.
OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
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Up to 60 Days Prior to Surgery
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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
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
2013年6月1日
一次修了 (実際)
2014年3月1日
研究の完了 (実際)
2014年3月1日
試験登録日
最初に提出
2013年6月18日
QC基準を満たした最初の提出物
2013年6月18日
最初の投稿 (見積もり)
2013年6月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年12月3日
QC基準を満たした最後の更新が送信されました
2015年11月2日
最終確認日
2015年11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。
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