Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
Sponsor
Glaukos Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03255785
Collaborator
(none)
50
1
31
Study Details
Study Description
Brief Summary
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
iStent and iStent SupraiStent and iStent Supra
Masking:
None (Open Label)
Masking Description:
IOP outcome masked
Primary Purpose:
Treatment
Official Title:
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent
Anticipated Study Start Date
:
May 1, 2018
Anticipated Primary Completion Date
:
Jun 1, 2020
Anticipated Study Completion Date
:
Dec 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: G1 plus G3 with phaco Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra |
Device: Cataract surgery plus one iStent and one iStent Supra implanted
Cataract surgery via phacoemulsfication plus one iStent and one iStent supra
|
Outcome Measures
Primary Outcome Measures
- 20% IOP reduction from baseline [Month 12]
IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
Secondary Outcome Measures
- IOP less than or equal to 18 mm Hg [Month 12]
IOP measured via Goldmann tonometry in mm Hg
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae
Exclusion Criteria:
- Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Glaukos Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT03255785
Other Study ID Numbers:
- GCF-040
First Posted:
Aug 21, 2017
Last Update Posted:
Mar 9, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms: