Primary Open Angle Glaucoma study: Hydrus Microstent vs Monofocal IOL
Official title Hydrus® Microstent New Enrollment Post-Approval Study
ClinicalTrials.gov ID: NCT04553523
What this study is testing
- What it's testing
- The study aims to find out how often the Hydrus Microstent moves out of position and what problems that might cause within two years.
- Who it's for
- This study is looking for people with open-angle glaucoma who are scheduled for cataract surgery.
- What's involved
- Participants will have standard cataract surgery with a new lens, plus the placement of a tiny drainage tube called the Hydrus Microstent.
- Time commitment
- The study follows participants for 24 months after the surgery to check on the device's position.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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 may apply.
You likely can't join if
- 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;
See the full eligibility 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 may apply.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
- Sioux City, Iowa, United States
- Overland Park, Kansas, United States
- Rockville, Maryland, United States
- Fraser, Michigan, United States
- Coon Rapids, Minnesota, United States
- Chesterfield, Missouri, United States
- Las Vegas, Nevada, United States
- Mason, Ohio, United States
- Cranberry Township, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- El Paso, Texas, United States
- Salt Lake City, Utah, United States
- Kenosha, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sacramento, California, United States; Sioux City, Iowa, United States; Overland Park, Kansas, United States; Rockville, Maryland, United States; Fraser, Michigan, United States; Coon Rapids, Minnesota, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.