Open-Angle GlaucomaNCT00326066
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
A study testing Glaucoma Surgery and cataract surgery only in people with Open-Angle Glaucoma, run by Glaukos Corporation at 9 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension. 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?
- Glaucoma Surgery and cataract surgery only
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Feb 2005to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
- All subjects must need cataract surgery.
Who cannot join
- Angle closure glaucoma
- Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Fellow eye already enrolled
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany3 sites
Mainz University
Mainz
Augenklinik der Technischen Universitat
Munich, 81675
Universitats- Augenklinik
Würzburg, D-97080
Netherlands2 sites
The Netherlands Ophthalmic Research Institute
Amsterdam
Ophthalmic Clinic
Rotterdam
Spain2 sites
Clinico San Carlos
Madrid, 28040
Instituto Oftalmológico de Aragón
Zaragoza, 50007
Turkey (Türkiye)1 site
Beyoglu Eye Research and Education Hospital
Istanbul
About this study
Official title: A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.
Read the detailed description
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.
- Conditions
- Open-Angle Glaucoma
- Being tested
- Glaucoma Surgery, cataract surgery only
- Keywords
- Open angle, Glaucoma, Surgery, 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.
Glaucoma SurgeryDevice
Also called two Glaukos iStent Trabecular Bypass Microstents
Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.
cataract surgery onlyProcedure or surgery
Also called Phacoemulsification
Subjects will undergo routine cataract surgery only (no stent implant).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: Glaucoma Surgery |
| 2 | Placebo comparator | Not described Receives: Procedure: cataract surgery only |
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 startFeb 2005
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT00326066
- Sponsor's protocol ID
- GCF-007
- Status last verified
- Mar 2018
- First submitted
- 12 May 2006
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.
PubMed 20207977
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00326066
- Acronym / sponsor ID
- GCF-007
- Conditions
- Open-Angle Glaucoma
- Keywords
- Open angle, Glaucoma, Surgery, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (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.
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.
Detailed description
The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Glaucoma Surgery |
| 2 | Placebo comparator | Procedure: cataract surgery only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
- All subjects must need cataract surgery.
Key exclusion criteria (4 listed)
- Angle closure glaucoma
- Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Fellow eye already enrolled
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 |
|---|---|---|
| Glaucoma SurgeryAlso: two Glaukos iStent Trabecular Bypass MicrostentsComparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension. | Device | 1 |
| cataract surgery onlyAlso: PhacoemulsificationSubjects will undergo routine cataract surgery only (no stent implant). | Procedure or surgery | 2 |
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 9 Mar 2018.
- Derived from this study: PubMed 20207977Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.
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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
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma Surgery and cataract surgery only in people with Open-Angle Glaucoma, run by Glaukos Corporation at 9 sites in 5 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 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Netherlands, Spain, Austria, Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
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 NCT00326066, which also lists 1 linked publication.
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 9 Mar 2018.