RECRUITINGPhase 4INTERVENTIONAL
Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
COMBINATION_PRODUCT
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
PROCEDURE
Sham procedure in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
Locations (1)
Glaukos Investigator Site
Kenosha, Wisconsin, United States