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OpenTrials
Completed

NCT Number: NCT01456390

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

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.V. Malayan Ophthalmological Center

Yerevan, 0001, Armenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iStent and iStent supra

Device

Implantation of two iStent devices and one iStent supra device

Primary outcomes

  1. Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP

    Time frame: 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 outcomes

  1. Mean diurnal IOP < 18mm Hg

    Time frame: 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 outcomes

  1. Safety/adverse event monitoring

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2011
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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