- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01882413
A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)
2015년 11월 2일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
204
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Manitoba
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Brandon, Manitoba, 캐나다
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Nova Scotia
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Halifax, Nova Scotia, 캐나다
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Ontario
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Barrie, Ontario, 캐나다
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Ottawa, Ontario, 캐나다
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Toronto, Ontario, 캐나다
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Quebec
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Boisbriand, Quebec, 캐나다
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients with planned cataract removal surgery
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 6월 1일
기본 완료 (실제)
2014년 3월 1일
연구 완료 (실제)
2014년 3월 1일
연구 등록 날짜
최초 제출
2013년 6월 18일
QC 기준을 충족하는 최초 제출
2013년 6월 18일
처음 게시됨 (추정)
2013년 6월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 12월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 11월 2일
마지막으로 확인됨
2015년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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