Evaluating standalone canaloplasty for glaucoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter clinical trial aims to assess the effectiveness of standalone canaloplasty procedures using two different devices: the iTrack™ Advance canaloplasty device and the OMNI® Surgical System. Participants will be randomized to receive one of the two interventions, focusing on patients with mild to moderate primary open-angle glaucoma. The study will measure intraocular pressure (IOP) outcomes and overall efficacy of the procedures. Eligible participants must be 22 years or older and have specific IOP measurements while on ocular hypotensive medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female subjects, 22 years or older at the time of surgery
* Diagnosed with mild to moderate primary open angle glaucoma
* Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy
* Intolerance to medical therapy OR need/willingness to reduce medications
* At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications
* At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 36 mmHg, and ≥ 3mmHg higher than medicated IOP
* Shaffer grade of ≥ 3 in all four quadrants
* Central corneal thickness ≥ 480µm and ≤ 620 µm
* Able and willing to comply with the study procedures and attend all follow-up visits
* Understands and signs the informed consent

Exclusion Criteria:

* Any of the following prior treatments for glaucoma (study eye):

  1. Laser trabeculoplasty

     i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty
  2. iStent or iStent Inject within 180 days of the Screening Visit
  3. Endocyclophotocoagulation (ECP) or Micropulse laser
  4. Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
  5. Prior canaloplasty (ab interno and ab externo)
  6. Prior goniotomy, or trabeculotomy (ab externo and ab interno)
  7. Hydrus microstent
  8. Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
  9. Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.)
* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma
* Cataract surgery within 6 months of the Screening Visit in the study eye
* History of fellow eye with cataract surgery within 30 days of Screening
* Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 36 mmHg
* Use of systemic medications (either current, within 30 calendar days of Screening exam, or anticipated) that may cause an increase in IOP, (e.g., systemic steroids including inhaled and oral steroids used on a regular basis)
* Ocular and/or systemic diseases that could affect the corneal endothelium (such as corneal endothelial dystrophy, intraocular inflammation and infection, or congenital abnormalities)
* History of penetrating keratoplasty or another corneal transplant
* BCVA of 20/200 or worse in the fellow eye not due to cataract
* Previous treatment with OMNI or iTrack (Note: permitted if fellow eye only was treated)
* BCVA of 20/50 or worse in the study eye not due to posterior capsular opacification

Where it's running

• Breyer Kaymak Klabe Augenchirurgie
  Düsseldorf, Germany Recruiting
• Hospital Clinico San Carlos, Servicio de Oftalmologia
  Madrid, Spain Recruiting
• Princess Alexandra Eye Pavilion, NHS Lothian
  Edinburgh, United Kingdom Recruiting
• St. Paul's Eye Unit, Liverpool University
  Liverpool, United Kingdom Recruiting
• Manchester Royal Eye Hospital
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Shamil Patel, MD, MBA — Eye Physicians and Surgeons of Arizona
• Study coordinator: Mike Pickrel
• Email: mpickrel@nova-eye.com
• Phone: 1-800-391-2316

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• G01 Eye Drops for Glaucomatous Optic Neuropathy

  This trial tests whether G01 Eye Drops can help people with open-angle glaucoma who also have optic nerve injury.

  Recruiting at 9 sites Phase 2 Qingdao WanMing BioCell Pharmaceutics Co.,Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07777861

• Additive Physical Activity for Hypothyroidism in Older Women with Glaucoma and Fatty Liver

  We’re testing whether adding a treadmill-based exercise program to standard thyroid treatment helps improve health in older women who have subclinical hypothyroidism, glaucoma, and fatty liver.

  Recruiting Cairo University · Dokki, Giza Governorate · NCT07599241

• Lifestyle changes plus nightly CPAP for glaucoma in people with sleep apnea

  This test checks whether adding a low-calorie diet and regular walking to nightly CPAP lowers eye pressure in people with high‑pressure open‑angle glaucoma who also have obstructive sleep apnea and obesity.

  Recruiting Cairo University · Giza, Dokki · NCT07447011

• Direct Selective Laser Trabeculoplasty to reduce glaucoma medications

  This study will try Direct Selective Laser Trabeculoplasty (DSLT) to reduce the number of eye-drop medications in adults with medically controlled primary open-angle glaucoma or ocular hypertension.

  Recruiting The Eye Institute of West Florida · Largo, Florida · NCT07390890

• Hexiris MIST device to lower eye pressure in people with primary open-angle glaucoma

  This trial will test the Hexiris MIST device to see if it lowers eye pressure in adults 40 and older whose primary open-angle glaucoma isn’t controlled by eye drops.

  Recruiting at 5 sites Hexiris Inc · Dieppe, New Brunswick and 4 other locations · NCT07358650

• PRESERFLO MicroShunt XI: patient experience follow-up after implantation for open-angle glaucoma

  A single-arm, post-market follow-up study to see how the PRESERFLO MicroShunt XI performs and whether it remains safe in adults with primary open angle glaucoma who aren’t controlled on medications.

  Recruiting at 10 sites Santen SAS · Vienna and 11 other locations · NCT07235592

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.