Travoprost Intraocular Implant + iStent Infinite
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Travoprost Intraocular Implant, iStent infinite, Sham procedure.
- Who it may be relevant to
- Registry conditions: Glaucoma, Open-Angle. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension
Overview
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
Interventions
- Drug Travoprost Intraocular Implant
anchored intracameral implant containing travoprost - Device iStent infinite
Successful iStent infinite surgery - Other Sham procedure
Sham procedure (to mimic placement of an iStent infinite)
Primary outcome measures
- change from baseline in mean diurnal intraocular pressure (IOP) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
Exclusion criteria
- unmedicated (washed out) IOP of >36 mmHg in the study eye
- hypersensitivity to travoprost or any other components of the travoprost intraocular implant
- vertical cup/disc ratio > 0.8 in the study eye
- best spectacle corrected visual acuity of worse than 20/80 in either eye
- any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Glaukos Clinical Study Site — Oklahoma City
Identifiers
NCT: NCT06066645 · GLK-101-01