Primary Open Angle GlaucomaHydrus IINCT01818115
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
A study testing Hydrus Implant and IOL placement in people with Primary Open Angle Glaucoma and Glaucoma, Open Angle, Pseudo-exfoliative, run by Ivantis, Inc. at 7 sites in 4 countries.
Trial summary
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Cataract Unilateral Pending Extraction
- What is being tested?
- Hydrus Implant and IOL placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jan 2011to Nov 2015
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
- Operable, age-related cataract eligible for phacoemulsification.
Who cannot join
- Closed Angle and narrow angle forms of Glaucoma.
- Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
About this study
Official title: A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
Read the detailed description
This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.
- Conditions
- Primary Open Angle Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Cataract Unilateral Pending Extraction
- Being tested
- Hydrus Implant, IOL placement
- Keywords
- POAG, PXG, IOL Surgery, CE Surgery
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus ImplantDevice
IOL placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| IOL placement with Hydrus Implant | Experimental | Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant Receives: Device: Hydrus Implant |
| IOL placement only. | Active comparator | Cataract Extraction with IOL placement only. Receives: Procedure: IOL placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.
The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment.
Measured: 24 months
Secondary outcomes (4)
Reduction in mean washed out IOP at 24 months
The mean diurnal IOP for each subject will be calculated and the sorted by group. The group average IOP will be compared to in-group baseline and between groups at the follow up time point.
Measured: 24 months
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
A 24 month visit will be conducted to confirm 12 month findings.
Measured: 12 months
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
A 24 month visit will be conducted to confirm 12 month findings.
Measured: 12 months
Diurnal IOP at 12 months following washout
A 24 month visit will be conducted to confirm 12 month findings
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivantis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Norbert Pfeiffer, MD, Principal investigator, Universitatsmedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818115
- Sponsor's protocol ID
- CP-10-001
- Acronym
- Hydrus II
- Status last verified
- Jan 2019
- First submitted
- 29 Feb 2012
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.
- ClinicalTrials.gov ID
- NCT01818115
- Acronym / sponsor ID
- Hydrus II / CP-10-001
- Conditions
- Primary Open Angle Glaucoma, Glaucoma, Open Angle, Pseudo-exfoliative, Cataract Unilateral Pending Extraction
- Keywords
- POAG, PXG, IOL Surgery, CE Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ivantis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
Detailed description
This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL placement with Hydrus Implant | Experimental | Device: Hydrus ImplantCataract extraction with intraocular lens (IOL) placement and Hydrus Implant |
| IOL placement only. | Active comparator | Procedure: IOL placementCataract Extraction with IOL placement only. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
- Operable, age-related cataract eligible for phacoemulsification.
Key exclusion criteria (2 listed)
- Closed Angle and narrow angle forms of Glaucoma.
- Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.
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 Implant | Device | IOL placement with Hydrus Implant |
| IOL placement | Procedure or surgery | IOL placement only. |
Primary outcome
Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.
Time frame: 24 months
The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment.
4 secondary outcomes
Reduction in mean washed out IOP at 24 months
Time frame: 24 months
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.
Time frame: 12 months
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.
Time frame: 12 months
Diurnal IOP at 12 months following washout
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Prof. Norbert Pfeiffer, MD principal investigator
Universitatsmedizin Mainz
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Implant and IOL placement in people with Primary Open Angle Glaucoma and Glaucoma, Open Angle, Pseudo-exfoliative, run by Ivantis, Inc. at 7 sites in 4 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 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Spain, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2019.