Hydrus® Microstent New Enrollment Post-Godkjenningsstudie (CONFIRM)
Hydrus® Microstent New Enrollment Post-Godkjenningsstudie: En prospektiv, ikke-randomisert, multisenter, enarms, klinisk studie
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alcon Call Center
- Telefonnummer: 1-888-451-3937
- E-post: alcon.medinfo@alcon.com
Studiesteder
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California
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Irvine, California, Forente stater, 92618
- Fullført
- Coastal Vision
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Sacramento, California, Forente stater, 95815
- Rekruttering
- Sacramento Eye Consultants
-
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Colorado
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Loveland, Colorado, Forente stater, 80538
- Rekruttering
- Eye Center of Northern Colorado
-
-
Iowa
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Sioux City, Iowa, Forente stater, 51104
- Rekruttering
- Jones Eye Center PC
-
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Kansas
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Overland Park, Kansas, Forente stater, 66213
- Har ikke rekruttert ennå
- Stiles Eyecare Excellence Cataracts and Glaucoma
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Maryland
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Rockville, Maryland, Forente stater, 20852
- Har ikke rekruttert ennå
- Visionary Eye Doctors
-
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Michigan
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Fraser, Michigan, Forente stater, 48026
- Rekruttering
- Fraser Eye Care Center
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-
Minnesota
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Coon Rapids, Minnesota, Forente stater, 55433
- Rekruttering
- Twin Cities Eye Consultants
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Missouri
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Chesterfield, Missouri, Forente stater, 63017
- Rekruttering
- Midwest Vision Research Foundation
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Kansas City, Missouri, Forente stater, 64154
- Har ikke rekruttert ennå
- Moyes Eye Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89145
- Rekruttering
- Center for Sight
-
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North Carolina
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Southern Pines, North Carolina, Forente stater, 28387
- Rekruttering
- Carolina Eye Associates PA
-
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Ohio
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Brecksville, Ohio, Forente stater, 44141
- Fullført
- Cleveland Eye Clinic
-
Cincinnati, Ohio, Forente stater, 45242
- Rekruttering
- Cincinnati Eye Institute
-
Mason, Ohio, Forente stater, 45040
- Har ikke rekruttert ennå
- Cincinnati Eye / Apex Eye
-
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Pennsylvania
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Cranberry Township, Pennsylvania, Forente stater, 16066
- Har ikke rekruttert ennå
- Scott & Christie and Associates, PC
-
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Texas
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Austin, Texas, Forente stater, 78731
- Rekruttering
- Texan Eye / Keystone Research
-
Dallas, Texas, Forente stater, 75231
- Har ikke rekruttert ennå
- Glaucoma Associates Of Texas
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El Paso, Texas, Forente stater, 79902
- Rekruttering
- El Paso Eye Surgeons
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Hurst, Texas, Forente stater, 76054
- Rekruttering
- Texas Eye Research Center
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Utah
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Salt Lake City, Utah, Forente stater, 84107
- Har ikke rekruttert ennå
- The Eye Institute of Utah
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Wisconsin
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Kenosha, Wisconsin, Forente stater, 53142
- Rekruttering
- Eye Centers Of Racine And Kenosha
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Project Lead, CDMA Surgical, Alcon Research
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP 18-001
- GLI314-C003 (Annen identifikator: Alcon Research)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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