RightFit
RecruitingPhase 4

Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma

iStent Infinite and iDose TR for Management of Moderate to Severe Primary Open Angle Glaucoma Are a Safe and Effective Alternative to Filtering Surgery for IOP Reduction in Patients With Medically Uncontrolled Glaucoma. (POAG)

Who can join

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

Age
18 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

Not stated in the study description — ask the study team about visits and procedures.

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 tests whether using iStent infinite and iDose TR together can safely lower eye pressure instead of filtering surgery. It is for people with moderate to severe open-angle glaucoma, an eye disease that can harm sight, that is not controlled with medical treatment.

The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.

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

Eligibility

Who can join

  • Have moderate to severe open-angle glaucoma, including primary, pigment-related, or pseudoexfoliation types.
  • Have a wide-open eye drainage angle with normal structure (Shaffer grade 3 or higher).
  • Can see hand movements or better.
  • Have vision field loss with a test score of -6 dB or worse.
  • Medicines and/or laser treatment have not controlled the glaucoma.
  • Glaucoma surgery that involves a cut in the eye is being considered as the next treatment.
  • Have your natural eye lens or an artificial lens.

Who can't join

  • Have glaucoma caused by injury, eye inflammation, or abnormal blood vessels, or have closed-angle glaucoma.
  • Have had glaucoma surgery that involved a cut in the eye.
  • Have had argon laser trabeculoplasty (ALT), a laser treatment for eye drainage.
  • Have had laser iridotomy, selective laser trabeculoplasty (SLT), or micropulse laser trabeculoplasty within the past 90 days.
  • Have active eye inflammation or swelling, or a significant disorder of the cornea, the clear front of the eye.
  • Have a cornea problem or another eye condition that prevents an accurate eye pressure reading with the study's pressure test.

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

Official eligibility criteria

Inclusion Criteria: * Moderate to severe open angle glaucoma (including POAG, PG, and PXG) * Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9 * Visual acuity HM or better * VF MD -6dB or worse * Failed medical therapy and/or laser treatment * Incisional glaucoma surgery contemplated as next intervention * Phakic or pseudophakic Exclusion Criteria: * Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma * Previous incisional glaucoma surgery * ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days * Active ocular inflammation or edema, clinically significant corneal dystrophy * Corneal or other pathology preventing accurate Goldmann applanation tonometry

Study sites (1)

PA