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

September 2, 2022 updated by: Glaukos Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia, 0001
        • S.V. Malayan Ophthalmological Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: iStent and iStent supra
Implantation of two iStent devices and one iStent supra device
Device: iStent and iStent supra
Implantation of two iStent devices and one iStent supra device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-61 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2011

Primary Completion (ACTUAL)

March 26, 2019

Study Completion (ACTUAL)

March 26, 2019

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (ESTIMATE)

October 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCF-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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