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
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Veronika Röggla, MD
- 電話番号:79450 01 40400
- メール:veronika.roeggla@meduniwien.ac.at
研究連絡先のバックアップ
- 名前:Christina Leydolt, MD
- 電話番号:79480 01 40400
- メール:christina.leydolt@meduniwien.ac.at
研究場所
-
-
-
Vienna、オーストリア、1090
- 募集
- Medical University of Vienna Allgemeines Krankenhaus
-
コンタクト:
- Rupert Menapace, Prof.
- 電話番号:014040066300
- メール:rupert.menapace@meduniwien.ac.at
-
コンタクト:
- Christina Leydolt, MD
- 電話番号:79480 01 40400
- メール:christina.leydolt@meduniwien.ac.at
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ: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.
|
アクティブコンパレータ: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.
|
アクティブコンパレータ: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.
|
アクティブコンパレータ: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.
|
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 |
---|---|---|
Agreement of the four devices measuring mean keratometry value.
時間枠:1 year
|
The measured K-Value of each device and the k-values within one device will be compared
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Agreement of the four devices measuring mean steep keratometry value.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Rupert Menapace, MD、Medical University of Vienna
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。