A Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward) (FlashForward)
A Prospective, Single-Center Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward)
The purpose of this study is to test the repeatability and reproducibility in Rod Intercept (RI) time with two AdaptDx Pro devices in healthy subjects with normal vision.
調査の概要
詳細な説明
This study is a prospective, single-center study to test the repeatability and reproducibility in Rod Intercept (RI) time with two AdaptDx Pro devices in healthy subjects with normal vision. Sixteen subjects will be enrolled. Both eyes will be evaluated.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Washington
-
Silverdale、Washington、アメリカ、98383
- 募集
- Pacific NorthWest Retina (Silverdale)
-
主任研究者:
- Todd Schneiderman, MD
-
コンタクト:
- Anna Rogers
- 電話番号:360-307-0300
- メール:a.rogers@pnwretina.com
-
-
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
サンプリング方法
調査対象母集団
Subjects who will be permitted into the study include those who meet all the inclusion criteria and have none of the exclusion criteria for both eyes at Visit 1 and confirmed at Visit 2.
説明
Inclusion Criteria (each eye qualifies for the study independently):
- Male or female between the ages of 22 and 49 (inclusive) at Visit 1
- ETDRS BCVA letter score of 85 (Snellen equivalent of 20/20) or better at Visit 1
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- Informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines
Exclusion Criteria (each eye qualifies for the study independently):
- Unable to follow simple instructions, operate a response button or maintain attention for 20 minutes
- Diagnosis or history of any ocular disease or disorder
- Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
- Presence of or history of malignancy within the past year of Visit 1 other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
- Is non-ambulatory
- History of drug, alcohol or substance abuse within 3 months prior to Visit 1
- Has received an investigational drug or treatment with an investigational device within 3 months prior to Visit 1
- In the opinion of the Investigator, is unlikely to comply with the study protocol
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
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
AdaptDx Pro Wearable
The updated AdaptDx Pro dark adaptation device |
The AdaptDx device measures changes in dark adaptation via rod intercept time. |
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 |
|---|---|---|
|
Rod Intercept Time (RIT)
時間枠:Immediately after test
|
Rod intercept time is the measure of time it takes for the human eye's rod photoreceptors to recover sensitivity and adjust from bright light to darkness |
Immediately after test
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- OPZ003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。