Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Official title

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

Overview

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Interventions

• Device Ab-interno canaloplasty utilizing the iTrack Advance device
  360 degree microcatheterization and viscodilation of Schlemm's canal
• Device Ab-interno canaloplasty utilizing the OMNI Surgical System
  360 degree microcatheterization and viscodilation of Schlemm's canal

Primary outcome measures

• The mean change in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline [Time frame: 12 months]
• Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at Month-12 compared to baseline and without any other intervention (medication or secondary surgery) [Time frame: 12 months]

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):

• Laser trabeculoplasty

i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty

• iStent or iStent Inject within 180 days of the Screening Visit
• Endocyclophotocoagulation (ECP) or Micropulse laser
• Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
• Prior canaloplasty (ab interno and ab externo)
• Prior goniotomy, or trabeculotomy (ab externo and ab interno)
• Hydrus microstent
• Suprachoroidal stent (e.g., Cypass, iStent Supra, MINIject)
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 3 centers

• Princess Alexandra Eye Pavilion, NHS Lothian — Edinburgh
• St. Paul's Eye Unit, Liverpool University — Liverpool
• Manchester Royal Eye Hospital — Manchester

Germany · 1 center

• Breyer Kaymak Klabe Augenchirurgie — Düsseldorf

Spain · 1 center

• Hospital Clinico San Carlos, Servicio de Oftalmologia — Madrid

Identifiers

NCT: NCT05786196 · NE 05021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗