Actively Recruiting
iStent Infinite and iDose TR Surgery for Moderate to Severe Primary Open Angle Glaucoma as an Alternative to Filtering Surgery for Eye Pressure Reduction
Led by Jonathon Myers · Updated on 2025-11-14
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
J
Jonathon Myers
Lead Sponsor
G
Glaukos Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining the minimally invasive iStent infinite trabecular micro-bypass system and the iDose TR (Travoprost intracameral Implant) in patients with moderate to severe open angle glaucoma that is not controlled by medication. This study aims to determine if this combination can serve as a safe and effective alternative to traditional filtering surgery for reducing intraocular pressure in these patients. The investigation focuses on measuring changes in eye pressure, medication use, additional surgeries, and adverse events. Participants will undergo surgery that uses the combined iStent infinite device and iDose TR drug implant to reduce eye pressure. This approach involves implanting both a micro-bypass stent and a drug depot into the eye during the procedure. The study does not include a comparison or placebo group; all participants will receive this combined treatment. Researchers will monitor participants over time to assess outcomes and safety. Throughout the study, participants will have their intraocular pressure measured, including diurnal pressure changes, and their use of glaucoma medications recorded. The need for further incisional glaucoma surgery and any side effects will also be tracked. Visual acuity and visual field measurements will be assessed to evaluate eye health. The main outcome is the reduction in intraocular pressure at 12 months compared to baseline. Participants' progress will be followed closely to ensure safety and effectiveness during the trial period.
CONDITIONS
Brief Title
Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate to severe open angle glaucoma including primary, pigmentary, and pseudoexfoliation types
- Open angle configuration with Shaffer grade 3 or higher and normal angle anatomy
- Visual acuity of hand motion or better
- Visual field mean deviation of -6 dB or worse
- Failed medical therapy and/or laser treatment
- Incisional glaucoma surgery planned as the next step
- Phakic or pseudophakic eye status
You will not qualify if you...
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Previous incisional glaucoma surgery
- Argon laser trabeculoplasty; history of iridotomy, selective laser trabeculoplasty, or micropulse laser trabeculoplasty within 90 days
- Active eye inflammation or edema, significant corneal dystrophy
- Corneal or other eye conditions preventing accurate Goldmann applanation tonometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo combined minimally invasive surgery using the iStent infinite trabecular micro-bypass system and receive the iDose TR drug implant.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months
Participants are monitored for intraocular pressure changes, medication use, need for additional surgery, and adverse events following surgery.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Wills Eye Hosital Glaucoma Dept.
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
M
Meskerem Divers
J
Jeanne L Molineaux, COA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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