Hydrus® Microstent 新規登録承認後試験 (CONFIRM)
Hydrus® Microstent 新規登録承認後研究: 前向き、無作為化、多施設、単群、臨床試験
The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
調査の概要
詳細な説明
Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Alcon Call Center
- 電話番号：1-888-451-3937
- メール：alcon.medinfo@alcon.com
研究場所
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California
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Irvine、California、アメリカ、92618
- 完了
- Coastal Vision
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Sacramento、California、アメリカ、95815
- 募集
- Sacramento Eye Consultants
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Colorado
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Loveland、Colorado、アメリカ、80538
- 募集
- Eye Center of Northern Colorado
-
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Iowa
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Sioux City、Iowa、アメリカ、51104
- 募集
- Jones Eye Center PC
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Kansas
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Overland Park、Kansas、アメリカ、66213
- まだ募集していません
- Stiles Eyecare Excellence Cataracts and Glaucoma
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Maryland
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Rockville、Maryland、アメリカ、20852
- まだ募集していません
- Visionary Eye Doctors
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Michigan
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Fraser、Michigan、アメリカ、48026
- 募集
- Fraser Eye Care Center
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Minnesota
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Coon Rapids、Minnesota、アメリカ、55433
- 募集
- Twin Cities Eye Consultants
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Missouri
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Chesterfield、Missouri、アメリカ、63017
- 募集
- Midwest Vision Research Foundation
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Kansas City、Missouri、アメリカ、64154
- まだ募集していません
- Moyes Eye Center
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Nevada
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Las Vegas、Nevada、アメリカ、89145
- 募集
- Center for Sight
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North Carolina
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Southern Pines、North Carolina、アメリカ、28387
- 募集
- Carolina Eye Associates PA
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Ohio
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Brecksville、Ohio、アメリカ、44141
- 完了
- Cleveland Eye Clinic
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Cincinnati、Ohio、アメリカ、45242
- 募集
- Cincinnati Eye Institute
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Mason、Ohio、アメリカ、45040
- まだ募集していません
- Cincinnati Eye / Apex Eye
-
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Pennsylvania
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Cranberry Township、Pennsylvania、アメリカ、16066
- まだ募集していません
- Scott & Christie and Associates, PC
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Texas
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Austin、Texas、アメリカ、78731
- 募集
- Texan Eye / Keystone Research
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Dallas、Texas、アメリカ、75231
- まだ募集していません
- Glaucoma Associates Of Texas
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El Paso、Texas、アメリカ、79902
- 募集
- El Paso Eye Surgeons
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Hurst、Texas、アメリカ、76054
- 募集
- Texas Eye Research Center
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Utah
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Salt Lake City、Utah、アメリカ、84107
- まだ募集していません
- The Eye Institute of Utah
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Wisconsin
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Kenosha、Wisconsin、アメリカ、53142
- 募集
- Eye Centers Of Racine And Kenosha
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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:
- An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
- Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
- Optic nerve appearance characteristic of glaucoma;
- Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Closed angle forms of glaucoma;
- Congenital or developmental glaucoma;
- Secondary glaucoma;
- Use of more than 4 ocular hypotensive medications;
- Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
- Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
- Other protocol-defined exclusion criteria may apply.
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：処理
- 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：Hydrus Microstent
Hydrus Microstent implanted in the eye immediately following cataract surgery and placement of a monofocal intraocular lens (IOL) |
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal immediately following placement of a monofocal IOL. Cataract surgery performed using standard anesthesia and phacoemulsification techniques Commercially available monofocal intraocular lens as determined by the investigator |
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 |
|---|---|---|
|
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
時間枠：Day 0 operative, up to Month 24 postoperative
|
The position of the implant will be assessed visually intraoperatively and at each postoperative follow-up visit. Examples of clinically significant device malposition associated with clinical sequelae as listed in the protocol include secondary surgical intervention to modify device position or to remove the device (explantation), corneal endothelial touch by device, iris touch by the device associated with intraocular inflammation, pigment dispersion or other sequelae, central endothelial cell loss ≥30 percent, compromised corneal function, best-corrected visual acuity (BCVA) loss of 2 lines (10 letters) or more on the ETDRS chart, device obstruction requiring secondary surgical intervention, persistent anterior chamber inflammation with peripheral anterior synechiae, persistent anterior chamber inflammation without peripheral anterior synechiae, and chronic pain. |
Day 0 operative, up to Month 24 postoperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of occurrence of intraoperative ocular adverse events
時間枠：Day 0 operative
|
Intraoperative ocular adverse events as specified in the protocol include hyphema obscuring the surgeon's view, choroidal hemorrhage or effusion, choroidal detachment, significant iris injury or trauma, corneal abrasion, corneal edema, zonular dialysis, cyclodialysis, cyclodialysis cleft, iridodialysis, vitreous loss not associated with the cataract procedure, inadvertent perforation of the sclera, and Descemet's membrane detachment. |
Day 0 operative
|
|
Rate of occurrence of sight threatening postoperative adverse events
時間枠：Up to Month 24
|
Sight threatening, post-operative adverse events as specified in the protocol include endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection. |
Up to Month 24
|
|
Rate of occurrence of other postoperative ocular adverse events
時間枠：Up to Month 24
|
Other postoperative ocular adverse events as specified in the protocol include anterior uveitis/iritis, non-persistent & persistent, best corrected visual acuity (BCVA) loss of 2 lines or more, chronic pain, device migration, device obstruction, peripheral anterior synechiae (PAS), ocular secondary surgical interventions for intraocular pressure (IOP) or glaucoma management, hypotony at or after 1 month postop, hyphema, corneal opacification, corneal edema persisting or severe corneal edema, other retinal complications, elevated mean IOP >/=10 millimeters mercury (mmHg) vs screening, iris prolapse/wound incarceration, significant foreign body sensation at or after 3 months postop, surgical re-intervention, and worsening of visual field. |
Up to Month 24
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Clinical Project Lead, CDMA Surgical、Alcon Research
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
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。