Trials / Completed
CompletedNCT03193736
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- iSTAR Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MINIject implant | MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2018-04-16
- Completion
- 2019-11-25
- First posted
- 2017-06-21
- Last updated
- 2021-02-17
- Results posted
- 2021-02-17
Locations
2 sites across 2 countries: India, Panama
Source: ClinicalTrials.gov record NCT03193736. Inclusion in this directory is not an endorsement.