Primary Open Angle GlaucomaNCT01539239
Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)
A study testing Hydrus Aqueous Implant and Cataract surgery in people with Primary Open Angle Glaucoma, run by Ivantis, Inc. at 38 sites in 9 countries.
Trial summary
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Hydrus Aqueous Implant and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,143 participants
- Where
- 38 sitesin 9 countries
- Study dates
- Jan 2012to Jun 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An operable age-related cataract
- A diagnosis of POAG treated with 1 to 4 hypotensive medications
- Medicated IOP ≤ 31 mmHg
- Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg
Who cannot join
- Congenital or developmental glaucoma
- Previous argon laser trabeculoplasty
- Ab-interno or ab-externo device implanted in or through Schlemm's Canal
- Use of oral hypotensive medication for glaucoma for treatment of fellow eye
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States26 sites
Study site
Austin, Texas
Study site
Bloomington, Minnesota
Study site
Bradenton, Florida
Study site
Chesterfield, Missouri
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Fayetteville, Arkansas
Study site
Fort Collins, Colorado
Study site
Fort Myers, Florida
Study site
Fort Worth, Texas
Study site
Garden City, Kansas
Study site
La Jolla, California
Study site
Louisville, Kentucky
Study site
Maryville, Tennessee
Study site
Mason, Ohio
Study site
Ocala, Florida
Study site
Orange, California
Study site
Parker, Colorado
Study site
Phoenix, Arizona
Study site
Racine, Wisconsin
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
Sandwich, Massachusetts
Study site
Sioux City, Iowa
Study site
Tucson, Arizona
Study site
Wilmington, North Carolina
United Kingdom3 sites
Study site
London
Study site
Manchester
Study site
Norwich
About this study
Official title: The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Hydrus Aqueous Implant, Cataract surgery
- Keywords
- Glaucoma, POAG, Cataract
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus Aqueous ImplantDevice
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Cataract surgeryProcedure or surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Aqueous Implant (Treatment) | Experimental | Cataract surgery plus Hydrus Aqueous Implant Receives: Device: Hydrus Aqueous Implant |
| Cataract Surgery (Control) | Active comparator | Cataract surgery only Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
Measured: Baseline and 24 months
Secondary outcomes (1)
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionJun 2020
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivantis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Crandall, MD, Principal investigator, The Eye institute of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539239
- Sponsor's protocol ID
- CP-11-001
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2012
- Last updated
- 12 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zebardast N, Zheng C, Jampel HD. Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial. Ophthalmology. 2020 Oct;127(10):1303-1310. doi: 10.1016/j.ophtha.2020.01.025. Epub 2020 Jan 23.
PubMed 32143828Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23.
PubMed 29945799
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01539239
- Acronym / sponsor ID
- CP-11-001
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Glaucoma, POAG, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,143 participants (actual)
- Lead sponsor
- Ivantis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrus Aqueous Implant (Treatment) | Experimental | Device: Hydrus Aqueous ImplantCataract surgery plus Hydrus Aqueous Implant |
| Cataract Surgery (Control) | Active comparator | Procedure: Cataract surgeryCataract surgery only |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An operable age-related cataract
- A diagnosis of POAG treated with 1 to 4 hypotensive medications
- Medicated IOP ≤ 31 mmHg
- Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg
Key exclusion criteria (4 listed)
- Congenital or developmental glaucoma
- Previous argon laser trabeculoplasty
- Ab-interno or ab-externo device implanted in or through Schlemm's Canal
- Use of oral hypotensive medication for glaucoma for treatment of fellow 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 Aqueous ImplantThe Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. | Device | Hydrus Aqueous Implant (Treatment) |
| Cataract surgeryA monofocal intraocular lens (IOL) placed during the cataract surgery. | Procedure or surgery | Cataract Surgery (Control) |
Primary outcome
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
Time frame: Baseline and 24 months
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
1 secondary outcome
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
Time frame: Baseline and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32143828Zebardast N, Zheng C, Jampel HD. Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial. Ophthalmology. 2020 Oct;127(10):1303-1310. doi: 10.1016/j.ophtha.2020.01.025. Epub 2020 Jan 23.
- Derived from this study: PubMed 29945799Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23.
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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.
Alan Crandall, MD principal investigator
The Eye institute of Utah
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Aqueous Implant and Cataract surgery in people with Primary Open Angle Glaucoma, run by Ivantis, Inc. at 38 sites in 9 countries.
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 4 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, United Kingdom, Canada, Spain, Germany and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 6 Sep 2019). 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?
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. (time frame: Baseline and 24 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 NCT01539239, which also lists 2 linked publications.
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 12 Mar 2021.