- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04323358
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract (Comparison)
The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.
The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.
Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Vienna, 오스트리아, 1090
- 모병
- Medical University of Vienna Allgemeines Krankenhaus
-
연락하다:
- Rupert Menapace, Prof.
- 전화번호: 014040066300
- 이메일: rupert.menapace@meduniwien.ac.at
-
연락하다:
- Christina Leydolt, MD
- 전화번호: 79480 01 40400
- 이메일: christina.leydolt@meduniwien.ac.at
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age-related cataract
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Exclusion Criteria:
- Contact lens wear within 5 days
- Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
- History of corneal ocular surgery
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: IOL Master® 700
Biometry will be performed three times consecutively.
|
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
|
활성 비교기: Pentacam®
Keratometry will be performed three times consecutively.
|
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
|
활성 비교기: Casia II®
Keratometry will be performed three times consecutively.
|
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
|
활성 비교기: Spectralis Anterion®
Biometry will be performed three times consecutively.
|
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Agreement of the four devices measuring mean keratometry value.
기간: 1 year
|
The measured K-Value of each device and the k-values within one device will be compared
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Agreement of the four devices measuring mean steep keratometry value.
기간: 1 year
|
The measured steep K-Value of each device and the steep k-values within one device will be compared
|
1 year
|
Agreement of the four devices measuring mean flat keratometry value.
기간: 1 year
|
The measured flat K-Value of each device and the flat k-values within one device will be compared
|
1 year
|
Agreement of the four devices measuring mean true keratometry value.
기간: 1 year
|
The measured true K-Value of each device and the true k-values within one device will be compared
|
1 year
|
Agreement of the devices measuring mean axial length
기간: 1 year
|
The measured axial length of each device and the axial length within one device will be compared
|
1 year
|
Agreement of the devices measuring mean lens thickness
기간: 1 year
|
The measured lens thickness of each device and the measured lens thickness within one device will be compared
|
1 year
|
Agreement of the devices measuring mean white-to-white measurement
기간: 1 year
|
The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
|
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Rupert Menapace, MD, Medical University of Vienna
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 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. .