Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma
Conditions
Keywords
POAG, PG, PXG
Brief summary
The Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
Detailed description
The Investigators will assess the mean intraocular pressure change from baseline, the change in the number of medications from baseline, the proportion of patients needing additional incisional surgery, and the incidence of adverse events. The Investigators hypothesize that patients receiving the combined standalone iStent infinite and iDose will experience a safe and significant reduction in mean intraocular pressure and number of medications during the study time period.
Interventions
DEVICEiStent infinite trabecular micro-bypass system model iS3
surgery perfomed using the iStent infinite trabecular micro-bypass system model iS3
DRUGiDose TR (Travoprost intracameral Implant) 75mcg
surgery performed using the iDose TR (Travoprost intracameral Implant) 75mcg
Sponsors
Glaukos Corporation
Jonathon Myers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Each patient will have surgery using the iStent infinite Trabecular Micro-bypass model iS3 and the iDose TR (Travoprost Intracameral Implant) 75mcg
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe open angle glaucoma (including POAG, PG, and PXG) * Open angle configuration (Shaffer grade ≥ 3), normal angle anatomy9 * Visual acuity HM or better * VF MD -6dB or worse * Failed medical therapy and/or laser treatment * Incisional glaucoma surgery contemplated as next intervention * Phakic or pseudophakic
Exclusion criteria
* Traumatic, uveitic, neovascular glaucoma, or angle closure glaucoma * Previous incisional glaucoma surgery * ALT; History of iridotomy, SLT, or micropulse laser trabeculoplasty within the prior 90 days * Active ocular inflammation or edema, clinically significant corneal dystrophy * Corneal or other pathology preventing accurate Goldmann applanation tonometry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP reduction from baseline | Diurnal IOP reduction from baseline at 12 months | a logistic regression model will be used for the imputation of missing values, using the 12-month performance outcome as dependent variable, and sex, race, age, baseline IOP, number of IOP-lowering medications used at baseline, last IOP and number of medications at the 6-month visit or later as explanatory variables. |
Countries
United States
Contacts
Primary ContactMeskerem Divers
Backup ContactJeanne L Molineaux, COA
Outcome results
None listed