Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
Recruiting · NCT07228221 · Interventional (participants receive a specific treatment) · Lead sponsor: Jonathon Myers
View the official record on ClinicalTrials.gov →Interventions studied
iDose TR (Travoprost intracameral Implant) 75mcgiStent infinite trabecular micro-bypass system model iS3
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Wills Eye Hosital Glaucoma Dept. - Philadelphia, Pennsylvania, United States