Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents

A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456390

Enrollment

Registered

2011-10-20

Start date

2011-09-30

Completion date

2019-03-26

Last updated

2022-09-07

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

Conditions

Open-Angle Glaucoma

Keywords

Open angle glaucoma, Prior trabeculectomy

Brief summary

Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.

Detailed description

Interventions

DEVICEiStent and iStent supra

Implantation of two iStent devices and one iStent supra device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs) * Open-angle glaucoma (including pseudoexfoliative)

Exclusion criteria

* Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs) * Prior ALT * Prior SLT within 90 days of screening visit

Design outcomes

Primary

Measure	Time frame	Description
Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP	12 Months	Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit

Secondary

Measure	Time frame	Description
Mean diurnal IOP < 18mm Hg	12 months	Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP \< 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit

Other

Measure	Time frame	Description
Safety/adverse event monitoring	0-61 months	Rate of ocular adverse events through 61 months * Findings from IOP, best corrected visual acuity, visual field, specular microscopy measurements * Findings from slit-lamp, fundus and gonioscopic examinations

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026