Evaluating standalone canaloplasty for glaucoma treatment

Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)

This study is testing two different devices for a procedure called canaloplasty to see which one works better for people with mild to moderate glaucoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Nova Eye, Inc. (industry)
• Locations: 5 sites (Düsseldorf and 4 other locations)
• Trial ID: NCT05786196 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older diagnosed with mild to moderate primary open-angle glaucoma who are candidates for canaloplasty surgery.

Not a fit: Patients who have previously undergone laser trabeculoplasty or have severe glaucoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with primary open-angle glaucoma, potentially reducing their reliance on medication.

How similar studies have performed: Other studies have shown promise with canaloplasty approaches, suggesting potential for success in this trial.

Eligibility criteria

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 this trial is running

Düsseldorf and 4 other locations

• 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

Conditions: Primary Open Angle Glaucoma, Canaloplasty