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

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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Cataract surgery plus one iStent and one iStent Supra implanted

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • Glaukos Investigator Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
20% IOP reduction from baseline	IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP less than or equal to 18 mm Hg	IOP measured via Goldmann tonometry in mm Hg	Month 12

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Glaucoma, Open-Angle; Cataract
• Other Study ID Numbers: GCF-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes