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NCT03255785 Clinical Trial

Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03255785
Other study ID # GCF-040
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 3, 2019

Study information
Verified date September 2022
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date December 3, 2019
Est. primary completion date December 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cataract surgery plus one iStent and one iStent Supra implanted
Cataract surgery via phacoemulsfication plus one iStent and one iStent supra

Locations
Country Name City State
Armenia Glaukos Investigator Sites Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 20% IOP reduction from baseline IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP Month 12
Secondary IOP less than or equal to 18 mm Hg IOP measured via Goldmann tonometry in mm Hg Month 12
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