Hydrus® Microstent New Enrollment Post-Approval Study (CONFIRM)
Hydrus® Microstent New Enrollment Post-Approval Study: En prospektiv, icke-randomiserad, multicenter, singelarm, klinisk prövning
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Alcon Call Center
- Telefonnummer: 1-888-451-3937
- E-post: alcon.medinfo@alcon.com
Studieorter
-
-
California
-
Irvine, California, Förenta staterna, 92618
- Avslutad
- Coastal Vision
-
Sacramento, California, Förenta staterna, 95815
- Rekrytering
- Sacramento Eye Consultants
-
-
Colorado
-
Loveland, Colorado, Förenta staterna, 80538
- Rekrytering
- Eye Center of Northern Colorado
-
-
Iowa
-
Sioux City, Iowa, Förenta staterna, 51104
- Rekrytering
- Jones Eye Center PC
-
-
Kansas
-
Overland Park, Kansas, Förenta staterna, 66213
- Har inte rekryterat ännu
- Stiles Eyecare Excellence Cataracts and Glaucoma
-
-
Maryland
-
Rockville, Maryland, Förenta staterna, 20852
- Har inte rekryterat ännu
- Visionary Eye Doctors
-
-
Michigan
-
Fraser, Michigan, Förenta staterna, 48026
- Rekrytering
- Fraser Eye Care Center
-
-
Minnesota
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Rekrytering
- Twin Cities Eye Consultants
-
-
Missouri
-
Chesterfield, Missouri, Förenta staterna, 63017
- Rekrytering
- Midwest Vision Research Foundation
-
Kansas City, Missouri, Förenta staterna, 64154
- Har inte rekryterat ännu
- Moyes Eye Center
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89145
- Rekrytering
- Center for Sight
-
-
North Carolina
-
Southern Pines, North Carolina, Förenta staterna, 28387
- Rekrytering
- Carolina Eye Associates PA
-
-
Ohio
-
Brecksville, Ohio, Förenta staterna, 44141
- Avslutad
- Cleveland Eye Clinic
-
Cincinnati, Ohio, Förenta staterna, 45242
- Rekrytering
- Cincinnati Eye Institute
-
Mason, Ohio, Förenta staterna, 45040
- Har inte rekryterat ännu
- Cincinnati Eye / Apex Eye
-
-
Pennsylvania
-
Cranberry Township, Pennsylvania, Förenta staterna, 16066
- Har inte rekryterat ännu
- Scott & Christie and Associates, PC
-
-
Texas
-
Austin, Texas, Förenta staterna, 78731
- Rekrytering
- Texan Eye / Keystone Research
-
Dallas, Texas, Förenta staterna, 75231
- Har inte rekryterat ännu
- Glaucoma Associates Of Texas
-
El Paso, Texas, Förenta staterna, 79902
- Rekrytering
- El Paso Eye Surgeons
-
Hurst, Texas, Förenta staterna, 76054
- Rekrytering
- Texas Eye Research Center
-
-
Utah
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Salt Lake City, Utah, Förenta staterna, 84107
- Har inte rekryterat ännu
- The Eye Institute of Utah
-
-
Wisconsin
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Kenosha, Wisconsin, Förenta staterna, 53142
- Rekrytering
- Eye Centers Of Racine And Kenosha
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of occurrence of clinically significant device malposition associated with clinical sequelae
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of occurrence of intraoperative ocular adverse events
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Project Lead, CDMA Surgical, Alcon Research
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CP 18-001
- GLI314-C003 (Annan identifierare: Alcon Research)
Plan för individuella deltagardata (IPD)
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