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Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will be followed for 24 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares cataract surgery alone with cataract surgery plus a procedure to widen the eye’s drainage canal using the iTrack Advance device. It is for people with mild to moderate primary open-angle glaucoma, a disease that damages the eye’s main nerve, and cataracts that affect vision. People in the study will be followed for 24 months.

A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have primary open-angle glaucoma with signs of mild to moderate disease.
  • Use 1 to 4 medicines to lower eye pressure at the screening visit and meet the study’s eye pressure rules.
  • Have a cataract, or cloudy eye lens, that affects vision.

Who can't join

  • Have had laser treatment for glaucoma in the study eye: laser trabeculoplasty, ECP, or Micropulse laser.
  • Have had a glaucoma stent, a small drainage device, placed in the study eye: iStent, iStent Inject, Hydrus, Cypass, iStent Supra, XEN, or MINIject.
  • Have had surgery to make a new drainage path in the study eye, such as trabeculectomy, Xen, Express, or a glaucoma drainage device or valve.
  • Have had canaloplasty, a procedure to widen the drainage canal, or iTrack treatment in the study eye. Prior iTrack treatment in the other eye is allowed.
  • Have had goniotomy or trabeculotomy, surgery to cut open drainage tissue, in the study eye.
  • Will have another procedure to lower eye pressure during surgery, besides the iTrack Advance procedure.
  • Have another listed type of glaucoma: acute angle closure (sudden blocked drainage), traumatic (from injury), congenital (present at birth), malignant (from trapped eye fluid), uveitic (from eye inflammation), or neovascular (from abnormal new blood vessels).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Mild to moderate, primary open angle glaucoma * Characteristics consistent with mild to moderate glaucoma * Use of 1 - 4 ocular hypotensive medications at the Screening exam and meets the IOP (intraocular pressure) criteria * Visually significant cataract Exclusion Criteria: Any of the following prior treatments for glaucoma (study eye): * Laser Trabeculoplasty * Endocyclophotocoagulation (ECP) or Micropulse laser * iStent or iStent Inject * Hydrus Microstent * Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma drainage device/valve. * Prior canaloplasty (ab-interno and ab-externo) * Prior goniotomy, or trabeculotomy (ab-interno or ab-externo) * Suprachoroidal stent (e.g., Cypass, iStent Supra, XEN, MINIject) * Concurrent IOP-lowering procedure other than use of the iTrackTM Advance canaloplasty device at the time of surgery (e.g., ECP, CPC, etc.) * Previous treatment with iTrack (Note: permitted if fellow eye only was treated) * Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

Study sites (1)

TX