Hydrus® Microstent New Enrollment Post-Godkendelsesundersøgelse (CONFIRM)
Hydrus® Microstent New Enrollment Post-Approval Study: Et prospektivt, ikke-randomiseret, multicenter, enkeltarms, klinisk forsøg
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Alcon Call Center
- Telefonnummer: 1-888-451-3937
- E-mail: alcon.medinfo@alcon.com
Studiesteder
-
-
California
-
Irvine, California, Forenede Stater, 92618
- Afsluttet
- Coastal Vision
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Sacramento, California, Forenede Stater, 95815
- Rekruttering
- Sacramento Eye Consultants
-
-
Colorado
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Loveland, Colorado, Forenede Stater, 80538
- Rekruttering
- Eye Center of Northern Colorado
-
-
Iowa
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Sioux City, Iowa, Forenede Stater, 51104
- Rekruttering
- Jones Eye Center PC
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Kansas
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Overland Park, Kansas, Forenede Stater, 66213
- Ikke rekrutterer endnu
- Stiles Eyecare Excellence Cataracts and Glaucoma
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Maryland
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Rockville, Maryland, Forenede Stater, 20852
- Ikke rekrutterer endnu
- Visionary Eye Doctors
-
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Michigan
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Fraser, Michigan, Forenede Stater, 48026
- Rekruttering
- Fraser Eye Care Center
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Rekruttering
- Twin Cities Eye Consultants
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
- Rekruttering
- Midwest Vision Research Foundation
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Kansas City, Missouri, Forenede Stater, 64154
- Ikke rekrutterer endnu
- Moyes Eye Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89145
- Rekruttering
- Center for Sight
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North Carolina
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Southern Pines, North Carolina, Forenede Stater, 28387
- Rekruttering
- Carolina Eye Associates PA
-
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Ohio
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Brecksville, Ohio, Forenede Stater, 44141
- Afsluttet
- Cleveland Eye Clinic
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Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Cincinnati Eye Institute
-
Mason, Ohio, Forenede Stater, 45040
- Ikke rekrutterer endnu
- Cincinnati Eye / Apex Eye
-
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Pennsylvania
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Cranberry Township, Pennsylvania, Forenede Stater, 16066
- Ikke rekrutterer endnu
- Scott & Christie and Associates, PC
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Texas
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Austin, Texas, Forenede Stater, 78731
- Rekruttering
- Texan Eye / Keystone Research
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Dallas, Texas, Forenede Stater, 75231
- Ikke rekrutterer endnu
- Glaucoma Associates Of Texas
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El Paso, Texas, Forenede Stater, 79902
- Rekruttering
- El Paso Eye Surgeons
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Hurst, Texas, Forenede Stater, 76054
- Rekruttering
- Texas Eye Research Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Ikke rekrutterer endnu
- The Eye Institute of Utah
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53142
- Rekruttering
- Eye Centers Of Racine And Kenosha
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of occurrence of intraoperative ocular adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Clinical Project Lead, CDMA Surgical, Alcon Research
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CP 18-001
- GLI314-C003 (Anden identifikator: Alcon Research)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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