Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

September 2, 2022 updated by: Glaukos Corporation

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study design is as follows:

  • Prospective, single-arm study.
  • Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
  • Subjects on two topical ocular hypotensive medications (one a prostaglandin).
  • Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued).
  • IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP.
  • Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout).
  • Descriptive statistics will be tabulated.
  • Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

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, 375108
        • S.V. Malayan's Ophtalmology Centre

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:

Screening Exam Inclusion Criteria:

  • Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
  • Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
  • C/D ratio ≤ 0.9
  • Visual field defects, or nerve abnormality characteristic of glaucoma
  • Two topical hypotensive medications at time of screening exam
  • IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
  • Study eye BCVA 20/100 or better
  • Normal angle anatomy as determined by gonioscopy
  • Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent

Baseline Exam Inclusion Criteria:

  • Subject has completed appropriate medication washout
  • Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
  • A 3mmHg IOP increase over screening mean IOP

Exclusion Criteria:

Screening Exam Exclusion Criteria:

  • Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
  • Prior stent implantations (study eye)
  • Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
  • Functionally significant visual field loss, including severe nerve fiber bundle defects
  • Prior incisional glaucoma surgery
  • Prior SLT within 90 days prior to screening
  • Prior ALT
  • Iridectomy or laser iridotomy
  • Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
  • Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
  • Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
  • Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
  • Corneal opacities that would inhibit visualization of the nasal angle
  • Congenital or traumatic cataract
  • Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
  • Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
  • Clinically significant sequelae from trauma
  • Chronic ocular inflammatory disease or presence of active ocular inflammation

Baseline Exam Exclusion Criteria:

  • Subject did not complete medication washout
  • Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
  • Subject does not have a 3mmHg IOP increase over screening mean diurnal

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2 micro-bypass stents & travoprost

Two iStent inject micro-bypass stents and topical travoprost

Intervention:

  • Implantation of two iStent inject micro-bypass stents
  • Tobramycin
  • Dexamethasone
Procedure: Implantation of two iStent inject micro-bypass stents
- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Other Names:
  • iStent inject
Drug: Topical travoprost
- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Other Names:
  • travoprost
Device: Two iStent inject micro-bypass stents
- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
Other Names:
  • iStent inject
Drug: Tobramycin

Topical antibiotic (tobramycin):

1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .

Drug: Dexamethasone

Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):

  • Week 1: 1 drop four (4) times per day in the study eye
  • Week 2: 1 drop three (3) times per day in the study eye
  • Week 3: 1 drop two (2) times per day in the study eye
  • Week 4: 1 drop one (1) time per day in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
Time Frame: 12 months postoperative
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication
Time Frame: 12 months postoperative
12 months postoperative

Collaborators and Investigators

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

Sponsor

Glaukos Corporation

Investigators

  • Principal Investigator: Lilit Voskanyan, MD, PhD, S.V. Malayan Eye Center

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)

March 1, 2013

Primary Completion (Actual)

November 8, 2019

Study Completion (Actual)

November 8, 2019

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 22, 2016

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCF-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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