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New treatment option for Primary Open Angle Glaucoma
Official title Multicenter Glaucoma Study Investigating Standalone Canaloplasty
ClinicalTrials.gov ID: NCT05786196
What this study is testing
- What it's testing
- 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.
- 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 22 and older
You may be able to join if
- Male or female people, 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
You likely can't join if
- 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)
See the full eligibility criteria
- Male or female people, 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
- 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
- people at significant risk by a washout of ocular hypotensive medication, and/or people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Düsseldorf, Germany
- Madrid, Spain
- Edinburgh, United Kingdom
- Liverpool, United Kingdom
- Manchester, United Kingdom
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 - 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, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Düsseldorf, Germany; Madrid, Spain; Edinburgh, United Kingdom; Liverpool, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.