Open-Angle GlaucomaPhase 4NCT00326014
A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
A Phase 4 study testing iStent in people with Open-Angle Glaucoma, run by Glaukos Corporation at 8 sites in 3 countries.
Trial summary
To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma
- What is being tested?
- iStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Apr 2003to Dec 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on at least one glaucoma medication
- Patient requiring cataract surgery and an intraocular lens implantation
Who cannot join
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Klinik Vincentinum
Augsburg, 86150
Universitats Augenklinik
Freiburg im Breisgau, 79106
Rotkreuz Krankenhaus
München, 80637
Klinikum Neubrandenburg
Neubrandenburg, 17033
Augenaerztliche Gemeinschaftspraxis
Weinheim, D69469
Spain2 sites
Clinico San Carlos
Madrid, 28040
Instituto Oftalmológico de Aragón
Zaragoza, 50007
About this study
Official title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.
Read the detailed description
Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)
- Conditions
- Open-Angle Glaucoma
- Being tested
- iStent
- Keywords
- Open angle, Glaucoma, Cataract, Surgery
- 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.
iStentDevice
Also called Glaukos iStent
Glaucoma Surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: iStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startApr 2003
- Primary completionMar 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of clinical Affairs, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326014
- Sponsor's protocol ID
- GC-002
- Status last verified
- Jun 2015
- First submitted
- 12 May 2006
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, Garcia-Feijoo J, Martinez-De-La-Casa JM, Garcia-Sanchez J. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009 May-Jun;19(3):393-9. doi: 10.1177/112067210901900311.
PubMed 19396784Spiegel D, Garcia-Feijoo J, Garcia-Sanchez J, Lamielle H. Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther. 2008 May;25(5):453-64. doi: 10.1007/s12325-008-0062-6.
PubMed 18594784
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
- ClinicalTrials.gov ID
- NCT00326014
- Acronym / sponsor ID
- GC-002
- Conditions
- Open-Angle Glaucoma
- Keywords
- Open angle, Glaucoma, Cataract, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 May 2006 (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.
To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.
Detailed description
Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: iStent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with primary open-angle glaucoma (POAG)
- Subject on at least one glaucoma medication
- Patient requiring cataract surgery and an intraocular lens implantation
Key exclusion criteria (2 listed)
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure 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 |
|---|---|---|
| iStentAlso: Glaukos iStentGlaucoma Surgery | Device | A |
Primary outcome
Efficacy
Time frame: 24 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 8 Jun 2015.
- Background: PubMed 19396784Spiegel D, Wetzel W, Neuhann T, Stuermer J, Hoeh H, Garcia-Feijoo J, Martinez-De-La-Casa JM, Garcia-Sanchez J. Coexistent primary open-angle glaucoma and cataract: interim analysis of a trabecular micro-bypass stent and concurrent cataract surgery. Eur J Ophthalmol. 2009 May-Jun;19(3):393-9. doi: 10.1177/112067210901900311.
- Background: PubMed 18594784Spiegel D, Garcia-Feijoo J, Garcia-Sanchez J, Lamielle H. Coexistent primary open-angle glaucoma and cataract: preliminary analysis of treatment by cataract surgery and the iStent trabecular micro-bypass stent. Adv Ther. 2008 May;25(5):453-64. doi: 10.1007/s12325-008-0062-6.
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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.
Head of clinical Affairs study director
Glaukos Corporation
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iStent in people with Open-Angle Glaucoma, run by Glaukos Corporation at 8 sites in 3 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 3 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Spain, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy (time frame: 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 NCT00326014, 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 8 Jun 2015.