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

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle
• Interventions: Device: Cataract surgery plus one iStent and one iStent Supra implanted

• Registration Number: NCT03255785
• Lead Sponsor: Glaukos Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Study Start: 2018-05-01
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
G1 plus G3 with phaco	Cataract surgery plus one iStent and one iStent Supra implanted	Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra

Primary Outcome Measures

Name	Time	Method
20% IOP reduction from baseline	Month 12	IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP

Secondary Outcome Measures

Name	Time	Method
IOP less than or equal to 18 mm Hg	Month 12	IOP measured via Goldmann tonometry in mm Hg

Trial Locations

Locations (1)

Glaukos Investigator Sites; 🇦🇲 Yerevan, Armenia