Analysis of Cataract Surgery Induced Dry Eye
Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
調査の概要
状態
条件
詳細な説明
The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.
The practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.
Because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Florida
-
Miami、Florida、アメリカ、33176
- William Trattler, MD
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- David Hardten, MD
-
-
New York
-
New York、New York、アメリカ、10021
- Chris Starr, MD
-
Rockville Centre、New York、アメリカ、11570
- Eric Donnenfeld, MD
-
-
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
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
説明
Inclusion Criteria:
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Exclusion Criteria:
1. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.
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
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 |
|---|---|---|
|
Post surgical tear osmolarity
時間枠:90-Day post-surgical
|
Correlation between pre-surgery value and development of dry eye disease post surgery 1) Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance |
90-Day post-surgical
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-surgical dry eye symptoms
時間枠:90-Day post-surgical
|
Correlation between pre-surgery value and development of dry eye disease post surgery. 1) Subjective patient reporting on dry eye symptoms from pre to postoperative |
90-Day post-surgical
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Gaston Lacayo, MD
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。