iDose TR Administration in an Office-Based Surgery Setting
Purpose
Clinical in-use observational trial to evaluate the administration of iDose TR (travoprost intracameral implant) in an office-based surgery setting.
Conditions
- Open Angle Glaucoma (OAG)
- Ocular Hypertension (OHT)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of Open angle glaucoma (OAG) or ocular hypertension (OHT)
Exclusion Criteria
- Prior administration of iDose TR or administration of an investigational intracameral implant in the study eye Active ocular infection or inflammation History of hypersensitivity to travoprost or implant components Recent ocular surgery Uncontrolled systemic disease Any condition preventing safe implantation
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| iDose TR | Travoprost Intracameral Implant |
|
Recruiting Locations
Glaukos Investigative Site
Austin, Texas 78746
Austin, Texas 78746
More Details
- Status
- Recruiting
- Sponsor
- Glaukos Corporation
Detailed Description
This study is a multicenter, single arm, open-label trial in adult subjects with open-angle glaucoma or ocular hypertension. The objective of the study is to assess the safety profile of iDose TR administration in an office-based surgery setting.