Actively Recruiting
The Hydrus Microstent New Enrollment Post-Approval Study: A Prospective, Non-Randomized, Multicenter, Single Arm, Clinical Trial
Led by Alcon Research · Updated on 2025-06-03
545
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the rate of Hydrus Microstent malposition and related clinical effects within 24 months after surgery in patients with primary open angle glaucoma undergoing cataract surgery. Participants will have an age-related cataract with vision of 20/40 or worse and will be treated with no more than four glaucoma medications. The study is sponsored by Alcon Research and involves a prospective, non-randomized, single-arm design. Participants will receive standard cataract surgery with placement of a monofocal intraocular lens (IOL), followed immediately by implantation of the Hydrus Microstent device. The Hydrus Microstent is a crescent-shaped device placed through the trabecular meshwork into Schlemm's canal to help fluid outflow from the eye. The study includes one treatment group receiving this combined surgical intervention. Participants will attend a screening visit, surgery day (Day 0), and eight follow-up visits over two years at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. During these visits, researchers will monitor device positioning, visual acuity, eye pressure, and any adverse events. The main outcome is the rate of significant device malposition related to clinical problems within 24 months after surgery. Safety and eye health will be closely followed throughout the study period.
CONDITIONS
Brief Title
Hydrus® Microstent New Enrollment Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years or older
- Presence of an operable, age-related cataract with best corrected visual acuity 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 intraocular pressure less than or equal to 31 millimeters mercury
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- 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 prior filtration or cilioablative surgery
- Prior surgery with implanted device or surgery involving the trabecular meshwork or Schlemm's canal
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo cataract surgery with placement of a monofocal intraocular lens followed by implantation of the Hydrus Microstent device.
1 surgical visit (in-person)
Duration - 24 months
Participants attend scheduled postoperative visits to monitor recovery and device performance.
8 visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 (in-person)
Trial Site Locations
Total: 22 locations
1
Coastal Vision
Irvine, California, United States, 92618
Completed
2
Sacramento Eye Consultants
Sacramento, California, United States, 95815
Actively Recruiting
3
Eye Center of Northern Colorado
Loveland, Colorado, United States, 80538
Actively Recruiting
4
Jones Eye Center PC
Sioux City, Iowa, United States, 51104
Actively Recruiting
5
Stiles Eyecare Excellence Cataracts and Glaucoma
Overland Park, Kansas, United States, 66213
Not Yet Recruiting
6
Visionary Eye Doctors
Rockville, Maryland, United States, 20852
Not Yet Recruiting
7
Fraser Eye Care Center
Fraser, Michigan, United States, 48026
Actively Recruiting
8
Twin Cities Eye Consultants
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
9
Midwest Vision Research Foundation
Chesterfield, Missouri, United States, 63017
Actively Recruiting
10
Moyes Eye Center
Kansas City, Missouri, United States, 64154
Not Yet Recruiting
11
Center for Sight
Las Vegas, Nevada, United States, 89145
Actively Recruiting
12
Carolina Eye Associates PA
Southern Pines, North Carolina, United States, 28387
Actively Recruiting
13
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
Completed
14
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
15
Cincinnati Eye / Apex Eye
Mason, Ohio, United States, 45040
Not Yet Recruiting
16
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
Not Yet Recruiting
17
Texan Eye / Keystone Research
Austin, Texas, United States, 78731
Actively Recruiting
18
Glaucoma Associates Of Texas
Dallas, Texas, United States, 75231
Not Yet Recruiting
19
El Paso Eye Surgeons
El Paso, Texas, United States, 79902
Actively Recruiting
20
Texas Eye Research Center
Hurst, Texas, United States, 76054
Actively Recruiting
21
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Not Yet Recruiting
22
Eye Centers Of Racine And Kenosha
Kenosha, Wisconsin, United States, 53142
Actively Recruiting
Research Team
A
Alcon Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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