Back to resultsOpen-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
Cataract surgery plus one iStent and one iStent Supra implanted
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
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
Sites / Locations
- Glaukos Investigator Sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
G1 plus G3 with phaco
Arm Description
Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra
Outcomes
Primary Outcome Measures
20% IOP reduction from baseline
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
IOP measured via Goldmann tonometry in mm Hg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255785
Brief Title
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
iStent and iStent Supra
Masking
None (Open Label)
Masking Description
IOP outcome masked
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G1 plus G3 with phaco
Arm Type
Experimental
Arm Description
Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra
Intervention Type
Device
Intervention Name(s)
Cataract surgery plus one iStent and one iStent Supra implanted
Intervention Description
Cataract surgery via phacoemulsfication plus one iStent and one iStent supra
Primary Outcome Measure Information:
Title
20% IOP reduction from baseline
Description
IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
IOP less than or equal to 18 mm Hg
Description
IOP measured via Goldmann tonometry in mm Hg
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Glaukos Investigator Sites
City
Yerevan
Country
Armenia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
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