Effect of Elevated Intraocular Pressure in Glaucoma Patients During Femtolaser Cataract Surgery (FEMTOHTO)
The use of the femtosecond laser causes an increase in the intraocular pressure (IOP) between 100 mm Hg and 200 mm Hg for a period of about 80 seconds (suction phase).
If it is known that elevated IOP accelerates the degradation of retinal ganglion cells, whose axons form the optic nerve.
No data has been published to date on potential adverse effects of femtolaser cataract surgery performed in patients with glaucomatous optic neuropathy.
Since some time, spectral-domain optical coherence tomography (SD -OCT) provides a detailed analysis of ganglion cell complex (GCC) for which the loss is a marker of glaucomatous optic neuropathy. The resolution of this device, about a few microns, can detect even a tiny loss of this layer.
The investigators propose to evaluate the effects of elevated intraocular pressure in glaucoma patients undergoing femtolaser cataract surgery, studying the GCC through SD-OCT.
調査の概要
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
-
-
-
Paris、フランス、75019
- Fondation ophtalmique Adolphe de Rothschild
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- scheduled bilateral cataract surgery
- bilateral known glaucoma confirmed at the preoperative consultation (glaucoma group) or absence of glaucoma in both eyes at confirmed the preoperative consultation (control group).
Exclusion Criteria:
- ophthalmologic pathology known other than glaucoma
diabetes
- untreated hypertension
- multiple sclerosis
- Graves' disease
- sarcoidosis
- patient taking toxic drug for the optic nerve and the retina
- neurodegenerative disease
- all general diseases that can affect the ocular structures
- eye surgery history
- patient's opposition to participation in the study, according to the law on research into routine care
- absence of affiliation to social security or to universal medical coverage
- legally protected patient
- pregnancy or breastfeeding
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：並列代入
- 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：Patient with glaucoma
Patient eligible for bilateral cataract surgery, with glaucoma.
Each patient is his own control.
The patient is treated with femtolaser surgery for one eye and with phacoemulsification for the other eye.
|
|
|
他の：Patient without glaucoma
Patient eligible for bilateral cataract surgery, without glaucoma.
Each patient is his own control.
The patient is treated with femtolaser surgery for one eye and with the phacoemulsification for the other eye.
|
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 |
|---|---|
|
In patient with glaucoma, measure of the thickness of the ganglion cell complex in the operated eye with femtosecond laser versus the operated eye with phacoemulsification.
時間枠：within the first 3 months after surgery
|
within the first 3 months after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。
Femtolaser surgeryの臨床試験
-
Bournemouth UniversityStryker Orthopaedics; Nuffield Health Bournemouth; Orthopaedic Research Institute完了
-
Piazza della Vittoria 14 Studio Medico - Ginecologia...募集
-
Kocaeli Derince Education and Research HospitalKocaeli Universityわからない
-
University of Illinois at ChicagoEthicon Endo-Surgery引きこもった