- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05215002
Quality Assurance Via Telephone Interviews After Cataract Surgery
연구 개요
상세 설명
As there is a trend towards shorter hospital stays, an increasing number of patients is leaving the hospital the same day after cataract surgery. There may be questions or complaints after the patients' dismissal after cataract surgery, consequently it might be useful to call patients at the day or one day after surgery in order to ask them about their concerns.
In general, possible complications after cataract surgery are explained to patients already before surgery and patients often receive additional written information. But as patients may still be uncertain whether it would be beneficial to visit a doctor in case of problems, it might be useful to call the patients and if necessary, advise them to see a doctor. During the phone call patients have the opportunity to ask more questions if something still does not seem clear.
For patients who are scheduled for cataract surgery for both eyes, the routine procedure is as follows: if cataract surgery is scheduled for both eyes, in general the surgeries are performed one week apart. Cataract surgery is usually performed under local anaesthesia and the patient can leave the department on the same day. When patients arrive at the department of ophthalmology for the second surgery, doctors evaluate the condition of the eye, operated the week before. After each surgery of each eye patients receive a prescription of topical medication. It is recommended to see the referring ophthalmologist within a week after the procedure. In case of problems or complaints patients are always told to see a doctor immediately. A respective written information is given to the patients.
During this study we plan to call patients, who are scheduled for cataract surgery for both eyes, in the evening of the day of the surgery or one day after the surgery of the first eye and to ask questions about their current condition for quality assessment. When people return for cataract surgery of the second eye, a questionnaire will be handed out to the patients. This questionnaire includes questions concerning problems after surgery of the first eye, visits in outpatint clinics and about their satisfaction with the phone call after the surgery of the first eye.
In this study 200 patients will be included: 100 patients will receive a telephone call (50 in the evening of the day of the surgery, 50 one day after surgery) and 100 patients who will not receive a phone call.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Oliver Findl, MD
- 전화번호: 57564 +43 (1) 91021
- 이메일: office@viros.at
연구 연락처 백업
- 이름: Manuel Ruiss, MD
- 전화번호: 57564 +43 (1) 91021
- 이메일: office@viros.at
연구 장소
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Vienna, 오스트리아, 1140
- 모병
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
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연락하다:
- Oliver Findl, MD
- 전화번호: 57564 +43 (1) 91021
- 이메일: office@viros.at
-
연락하다:
- Manuel Ruiss, MSc
- 전화번호: 57564 +43 (1) 91021
- 이메일: office@viros.at
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Telephone call
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
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Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
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실험적: No telephone call
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
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Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patients
기간: 24 months
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The number of patients in group 1 and group 2 seen at the outpatient clinic between surgery of the first and the second eye will be documented
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient's Satisfaction
기간: 24 months
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Patient's satisfaction with the telephone call after cataract surgery will be assessed with a question asking the patient if she/ he liked the call (5 answering options: very, a little, I don't know, no, absolutely not)
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24 months
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Patient's Symptoms
기간: 24 months
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Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
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24 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
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미국 FDA 규제 기기 제품 연구
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