Assessment of Scan Quality of Sparse OCT Retina Scanner (MimoStudy01)
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
調査の概要
詳細な説明
Background
Optical Coherence Tomography (OCT) is an established non-invasive medical imaging technique ophthalmologists use to diagnose and monitor retinal diseases such as age-related macular degeneration (AMD).
This study assesses the scanning performance of a newly developed sparse OCT retina scanner that is smaller and more compact than most commercially available medical OCT systems. The prototype device was developed at Artorg Center Bern and Berner Fachhochschule Biel.
In this study the device is first tested on human eyes. The scanning performance is compared to a reference device. Additionally patient feedback during the examination is acquired.
The findings of this study are used to improve the software and the ergonomics of the investigational device.
Objective
- Comparing scan quality of investigational device to scan quality of reference device.
- Obtaining patient feedback on the examination with investigational device.
Methods
Comparison of OCT scans made with standard device and investigational device.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
ZH
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Zürich、ZH、スイス、8006
- Augenklinik Univestitätspital Zürich
-
-
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:
- 18 years or older
- German speaking
- Suffering from age-related macular degeneration
- Written informed consent
Exclusion Criteria
- Epilepsy
- Parkinsonian syndrome
- Dementia
- Pregnant women
- Persons using electronic medical aids i.e. hearing aid, pacemaker..
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：All study participants
Patient's eyes are OCT-scanned with standard device and investigational device.
|
OCT scan (as yet unnamed) of the eye with investigational device; newly developed sparse OCT retina scanner by Artorg Center Bern and Berner Fachhochschule Biel
|
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 |
時間枠 |
|---|---|
|
Distance between ILM and RPE (IPD) measurement successful or not. Successful is defined as a) measurement performed/failed, and if performed, b) value obtained within ±10% of value of reference OCT device.
時間枠：During diagnostic intervention, expected to be ca. 30 minutes on average
|
During diagnostic intervention, expected to be ca. 30 minutes on average
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient comfort during examination
時間枠：Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Assessed via interview with patient
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
|
Duration of OCT examination with investigational device
時間枠：Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
Directly after diagnostic intervention, expected to be ca. 35 minutes on average
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sandrine Zweifel, MD、Augenklinik Universitätspital Zürich
- スタディディレクター：Raphael Sznitman、ARTORG, University of Bern
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。