Primary Open Angle GlaucomaNCT02024464

Comparing Hydrus Microstent(TM) to the iStent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery

A study testing Hydrus Microstent, iStent Trabecular Micro Bypass and Cataract removal and intraocular lens (IOL) implantation in people with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by Ivantis, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. One of the two devices will be implanted immediately following cataract surgery and the placement of a posterior chamber intra-ocular lens. Only one eye (study eye) will be implanted. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma
What is being tested?: Hydrus Microstent, iStent Trabecular Micro Bypass and Cataract removal and intraocular lens (IOL) implantation
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: No sites listed yet
Study dates: Aug 2011to Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Who cannot join

Forms of primary or secondary glaucoma not listed above
Prior glaucoma surgery in the study eye

About this study

Official title: A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

Read the detailed description

This is a prospective, multicenter, single-masked, randomized clinical trial comparing Cataract Extraction (CE) + Hydrus Microstent to CE surgery + iStent implant for the reduction of intraocular pressure in patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma with an operable cataract. Eligible patients will be scheduled for cataract surgery. At the conclusion of successful cataract surgery and the placement of a posterior-chamber IOL, qualified subjects will be randomized to receive either the Hydrus Microstent or the iStent implant. Post-operative follow-up visits will be conducted at regular intervals.

Conditions: Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma
Being tested: Hydrus Microstent, iStent Trabecular Micro Bypass, Cataract removal and intraocular lens (IOL) implantation
Keywords: Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus
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.

Hydrus MicrostentDevice
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
iStent Trabecular Micro BypassDevice
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Cataract removal and intraocular lens (IOL) implantationProcedure or surgery
Cataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects

Study groups in NCT02024464
Study group	Role	What they receive
Hydrus Microstent	Experimental	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye) Receives: Device: Hydrus Microstent; Procedure: Cataract removal and intraocular lens (IOL) implantation
iStent	Active comparator	Cataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye) Receives: Device: iStent Trabecular Micro Bypass; Procedure: Cataract removal and intraocular lens (IOL) implantation

What is being measured

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

Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Measured: Month 12: 8 am, 12 pm, 4 pm

Secondary outcomes (2)

Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Measured: Month 12: 8 am, 12 pm, and 4 pm
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.
Measured: Month 12: 8 am, 12 pm, 4 pm

Timeline

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

Aug 2011Aug 2018

First posted31 Dec 2013 (estimated)
Study startAug 2011
Primary completionMar 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02024464
Sponsor's protocol ID: CP-10-002
Status last verified: Jun 2024
First submitted: 20 Dec 2013
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
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Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
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The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
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Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
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Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Comparison of the Hydrus Microstent to the iStent for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
ClinicalTrials.gov ID: NCT02024464
Acronym / sponsor ID: CP-10-002
Conditions: Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Dispersion Glaucoma
Keywords: Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary dispersion glaucoma, PDG, Hydrus
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Ivantis, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Mar 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Hydrus Microstent	Experimental	Device: Hydrus Microstent, Procedure: Cataract removal and intraocular lens (IOL) implantationCataract removal and intraocular lens (IOL) implantation, followed by insertion of the Hydrus Microstent in one eye (study eye)
iStent	Active comparator	Device: iStent Trabecular Micro Bypass, Procedure: Cataract removal and intraocular lens (IOL) implantationCataract removal and intraocular lens (IOL) implantation, followed by insertion of the iStent Trabecular Micro Bypass in one eye (study eye)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary dispersion glaucoma (PDG)
An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification.

Key exclusion criteria (2 listed)

Forms of primary or secondary glaucoma not listed above
Prior glaucoma surgery in the study eye

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrus MicrostentDevice inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.	Device	Hydrus Microstent
iStent Trabecular Micro BypassDevice inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.	Device	iStent
Cataract removal and intraocular lens (IOL) implantationCataract removal with phacoemulsification using standard techniques, followed by implantation with a posterior-chamber IOL suitable for glaucoma subjects	Procedure or surgery	Hydrus Microstent, iStent

Primary outcome

Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12
Time frame: Month 12: 8 am, 12 pm, 4 pm
Intraocular pressure (IOP) was measured using Goldmann applanation tonometry and averaged over the 8 am, 12 pm, and 4 pm time points. IOP was recorded in millimeters mercury (mmHg). The IOP assessment occurred after a protocol-specified wash-out period from all glaucoma medications.

2 secondary outcomes

Percentage of Subjects With 20% Reduction From Baseline in Unmedicated DIOP at Month 12
Time frame: Month 12: 8 am, 12 pm, and 4 pm
Percentage of Subjects With Unmedicated DIOP of Not Less Than 5 mmHg and Not More Than 18 mmHg at Month 12
Time frame: Month 12: 8 am, 12 pm, 4 pm

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydrus Microstent	154	144
iStent	152	141

Primary outcome: Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12

Time frame: Month 12: 8 am, 12 pm, 4 pm. Mean (Standard Deviation). Unit: mmHg

Measure	Hydrus Microstent n = 139	iStent n = 141
Value	16.9 (4.5)	18.1 (4.9)

Population analysed: Intent-to-Treat (ITT) with verifiable data at visit. ITT subjects with secondary glaucoma or pressure lowering procedures, terminal wash-out exemptions, or missed diurnal IOP assessments are counted as failures for response metrics and are assigned a zero value for change in DIOP for the effectiveness endpoints.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of surgery to study exit, approximately 24 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydrus Microstent	2 of 154 (1.3%)	24 of 154 (15.6%)	4 of 154
iStent	8 of 152 (5.3%)	16 of 152 (10.5%)	3 of 152

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Primary Open Angle Glaucoma

Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 2 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Unmedicated Mean Diurnal Intraocular Pressure (DIOP) at Month 12 (time frame: Month 12: 8 am, 12 pm, 4 pm). 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 NCT02024464.

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 3 Jul 2024.