Glaucoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 22 or older at the time of their surgery
• People who have been diagnosed with mild to moderate primary open-angle glaucoma (a common type of glaucoma)
• People whose condition makes them a suitable candidate for a specific type of eye surgery called canaloplasty, which involves widening a drainage channel in the eye without cutting it
• People who cannot tolerate their current eye pressure-lowering eye drops, or who want or need to reduce the number of drops they use
• People whose eye pressure, while still on eye drops, measures 30 mmHg or below at the screening visit
• People whose eye pressure, after stopping eye drops, measures between 21 and 36 mmHg at the baseline visit, and is at least 3 mmHg higher than when on drops
• People whose eye drainage angle is assessed as sufficiently open in all four sections of the eye (Shaffer grade 3 or higher — confirm with trial site)
• People whose corneal (front of the eye) thickness falls between 480 and 620 micrometres
• People who are able and willing to follow all study procedures and attend all required follow-up visits
• People who understand and sign the informed consent form

Who may not be able to join:

• People who have had certain previous glaucoma treatments in the eye being studied, including: a type of laser treatment called Selective Laser Trabeculoplasty (SLT) within the past 6 months, or Argon Laser Trabeculoplasty at any time
• People who have had certain small implanted devices (iStent or iStent Inject) placed in the study eye within the past 180 days
• People who have had specific laser treatments called Endocyclophotocoagulation (ECP) or Micropulse laser in the study eye
• People who have had a trabeculectomy or other surgery that creates a fluid drainage blister in the eye (including Xen, Express, or glaucoma drainage valves)
• People who have previously had canaloplasty surgery (either approach) in the study eye
• People who have previously had goniotomy or trabeculotomy surgery in the study eye
• People who have had a Hydrus microstent placed in the study eye
• People who have had a suprachoroidal stent (such as Cypass, iStent Supra, or MINIject) placed in the study eye
• People who would need another eye pressure-lowering procedure at the same time as the study surgery, other than the specific devices being studied
• People whose glaucoma is caused by or related to certain other conditions, such as sudden angle closure, eye injury, a condition present from birth, inflammation, abnormal blood vessels, pigment dispersion, or protein build-up in the eye
• People who have had cataract surgery in the study eye within the past 6 months
• People whose other eye had cataract surgery within 30 days before the screening visit
• People for whom stopping eye pressure-lowering drops would carry significant health risks, or whose eye pressure without drops is expected to go above 36 mmHg
• People currently taking, or who have taken within the past 30 days, certain medicines taken by mouth or inhaled (such as regular steroid medications) that may raise eye pressure
• People with certain eye or general health conditions that could affect the inner layer of the cornea, such as corneal cell disease, eye inflammation or infection, or conditions present from birth
• People who have had a corneal transplant of any kind
• People whose other (non-study) eye has vision of 20/200 or worse, for reasons other than cataracts
• People who have previously been treated with the OMNI or iTrack devices in the study eye (treatment in the other eye only is permitted)
• People whose study eye has vision of 20/50 or worse, for reasons other than a cloudy lens after cataract surgery

Important: Always verify eligibility with the trial site directly before applying.