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Primary Open Angle GlaucomaNCT01841450

Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

A study testing iStent and Cataract surgery in people with Primary Open Angle Glaucoma, run by Glaukos Corporation at 14 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Primary Open Angle Glaucoma
What is being tested?
iStent and Cataract surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
14 sitesUnited States
Study dates
Jul 2013to Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • mild to moderate primary open-angle glaucoma
  • currently treated with ocular hypotensive medication
  • pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
  • subject scheduled to undergo cataract surgery

Who cannot join

  • primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
  • retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Edgewood, Kentucky, 41017

  • Study site

    Irvine, California, 92604

  • Study site

    Jackson, Michigan, 49202

  • Study site

    Kansas City, Missouri, 64151

  • Study site

    Kingston, Pennsylvania, 18704

  • Study site

    Louisville, Kentucky, 40217

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Montebello, California, 90640

  • Study site

    Saint Joseph, Michigan, 49085

  • Study site

    St Louis, Missouri, 63131

  • Study site

    Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Read the detailed description

The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Being tested
iStent, Cataract surgery
Keywords
Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
Medical subject headings
Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iStentDevice

    Also called GTS100

    Implantation of one iStent in conjunction with cataract surgery

  • Cataract surgeryProcedure or surgery

    Cataract surgery alone

Study groups in NCT01841450
Study groupRoleWhat they receive
iStentExperimentalImplantation of one iStent in conjunction with cataract surgery
Receives: Device: iStent
Cataract surgeryActive comparatorCataract surgery alone
Receives: Procedure: Cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of sight-threatening adverse events

    Measured: 36 months

Secondary outcomes (1)

  1. Other adverse events

    For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionAug 2021
  4. Study completionNov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01841450
Sponsor's protocol ID
GTS100-PAS2 (Rev1 04-11-2016)
Status last verified
Oct 2021
First submitted
24 Apr 2013
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing iStent and Cataract surgery in people with Primary Open Angle Glaucoma, run by Glaukos Corporation at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of sight-threatening adverse events (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01841450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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