Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone
Recruiting · NCT06848946 · Interventional (participants receive a specific treatment) · Lead sponsor: Glaukos Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Sham procedure in conjunction with cataract surgeryiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
What this trial is about
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Who can take part
Age range
45 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
- 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 it is running
1 location listed across 1 US state.
- Glaukos Investigator Site - Kenosha, Wisconsin, United States