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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03255785

Enrollment

Registered

2017-08-21

Start date

2018-05-01

Completion date

2019-12-03

Last updated

2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

Brief summary

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

Interventions

DEVICECataract surgery plus one iStent and one iStent Supra implanted

Cataract surgery via phacoemulsfication plus one iStent and one iStent supra

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

IOP outcome masked

Intervention model description

iStent and iStent Supra

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026