Trial comparing treatments for Primary Open Angle Glaucoma
Official title Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
ClinicalTrials.gov ID: NCT05564091
What this study is testing
- What it's testing
- The study compares two eye‑surgery plans to see which better manages glaucoma after cataract removal.
- Who it's for
- Adults with mild or moderate primary open‑angle glaucoma who need cataract surgery.
- What's involved
- Participants will have cataract surgery, and half will also get ab‑in‑terno canaloplasty with the iTrack Advance device. They will have follow‑up visits and eye tests over time.
- Time commitment
- The study lasts 24 months, with scheduled visits and eye exams during that period.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
You likely can't join if
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
- Prior canaloplasty (ab-interno and ab-externo)
See the full eligibility criteria
- Mild to moderate, primary open angle glaucoma
- Characteristics consistent with mild to moderate glaucoma
- Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria
- Visually significant cataract
- Laser Trabeculoplasty
- Endocyclophotocoagulation (ECP) or Micropulse laser
- iStent or iStent Inject
- Hydrus Microstent
- Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve.
- Prior canaloplasty (ab-interno and ab-externo)
- Prior goniotomy, or trabeculotomy (ab-interno or ab-externo)
- Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject)
- Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.)
- Previous treatment with iTrack (Note: permitted if fellow eye only was treated)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
The study team makes the final eligibility decision.
Where it is enrolling
- Sugar Land, Texas, United States
- Bonn, Germany
- Cologne, Germany
- Dortmund, Germany
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, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sugar Land, Texas, United States; Bonn, Germany; Cologne, Germany; Dortmund, Germany. 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.