Evaluating the safety and effectiveness of iDose TR with cataract surgery
Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
This study is testing if adding the iDose TR implant during cataract surgery can safely lower eye pressure better than just having cataract surgery alone for people with glaucoma or high eye pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Kenosha, Wisconsin) |
| Trial ID | NCT06848946 on ClinicalTrials.gov |
What this trial studies
This trial assesses the safety and intraocular pressure (IOP) lowering effects of the iDose TR (travoprost intracameral implant) when administered during cataract surgery compared to cataract surgery alone. It is a Phase 4 randomized, double-masked, parallel group trial involving patients diagnosed with open-angle glaucoma or ocular hypertension. The study aims to determine if the combination of iDose TR and cataract surgery provides better outcomes than cataract surgery by itself.
Who should consider this trial
Good fit: Ideal candidates include patients with clinically significant age-related cataracts and a diagnosis of open-angle glaucoma or ocular hypertension.
Not a fit: Patients with active corneal inflammation, edema, or retinal disorders not associated with glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve IOP management in patients undergoing cataract surgery who have glaucoma or ocular hypertension.
How similar studies have performed: Other studies have explored similar approaches, but the specific combination of iDose TR with cataract surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Active corneal inflammation or edema. * Retinal disorders not associated with glaucoma.
Where this trial is running
Kenosha, Wisconsin
- Glaukos Investigator Site — Kenosha, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Study Manager
- Email: ClinicalResearch@glaukos.com
- Phone: 949-739-8749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.