iDose TR with Cataract Surgery for Glaucoma or Ocular Hypertension

This study is looking at the safety and effectiveness of iDose TR (a travoprost implant) when given during cataract surgery. It compares this approach to cataract surgery alone for people with open-angle glaucoma (OAG) or ocular hypertension (OHT), which is high pressure in the eye. You might be able to join if you are 45 or older, need cataract surgery, and have OAG or OHT. The main goal is to see how much the eye pressure changes after 3 months. The study is currently unclear on its recruitment status.

Study design
This is a Phase 4, randomized, double-masked study involving 132 participants. It compares two groups: one receiving iDose TR during cataract surgery and another receiving a sham procedure during cataract surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 3 months to measure changes in eye pressure.

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NCT06848946

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Recruiting
PHASE4Ages 45+InterventionalTreatment
Glaukos Corporation
~132 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgerySham procedure in conjunction with cataract surgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in mean diurnal IOP
Measured over 3 Months
Glaucoma, Open-angle
Ocular Hypertension (OHT)
Phacoemulsification Cataract Surgery
1 sites across 1 states
Wisconsin1
  • Study Director · STUDY_CHAIR · Glaukos Corporation

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Eligibility criteria

Inclusion

Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion

Active corneal inflammation or edema.
Retinal disorders not associated with glaucoma.
  • Change from baseline in mean diurnal IOP3 Months

    Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit