Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Launched by NOVA EYE, INC. · Mar 14, 2023

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ClinConnect Summary

This clinical trial is studying a procedure called canaloplasty, which is a treatment for primary open-angle glaucoma, a common eye condition that can lead to vision loss. Researchers want to find out how effective canaloplasty is when performed alone, using a special device called the iTrack™ Advance, compared to another device known as the OMNI® Surgical System. The trial is taking place at multiple centers and is currently looking for participants.

To be eligible for the trial, individuals must be at least 22 years old and have been diagnosed with mild to moderate glaucoma. Participants should also be candidates for canaloplasty and may need to reduce their eye medication or have already found it hard to continue using it. The study will involve several visits to monitor their eye pressure and overall progress. This trial is important because it aims to improve treatment options for those living with glaucoma, potentially leading to better eye health and quality of life.

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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