Open-Angle GlaucomaPhase 3NCT00323284
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
A Phase 3 study testing iStent plus Cataract Surgery and Cataract surgery only in people with Open-Angle Glaucoma, run by Glaukos Corporation at 31 sites in United States.
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 open-angle glaucoma or ocular hypertension and co-existing cataract. 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 plus Cataract Surgery and Cataract surgery only
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2005to Mar 2010
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
- Subject on at least one glaucoma medication
- Able and willing to attend follow up visits for two years post operative
- Able and willing to sign informed consent
Who cannot join
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
- Fellow eye already enrolled
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Williamson Nelson Eye Center
Baton Rouge, Louisiana, 70806
Southeast Texas Medical Association, L.L.P.
Beaumont, Texas, 77702
Assil Eye Institute
Beverly Hills, California, 90210
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
Laurel Eye Center
Brookville, Pennsylvania, 15825
Cinicinnati Eye Institute
Cincinnati, Ohio, 45242
Kresge Eye Institute
Detroit, Michigan, 48201
Chu Vision Institute
Edina, Minnesota, 55435
Donald J. Digby and Associates
Greensboro, North Carolina, 27408
Discover Vision Centers
Independence, Missouri, 64055
Indiana University
Indianapolis, Indiana, 46260
Silverstein Eye Centers
Kansas City, Missouri, 64133
The Shepherd Eye Center
Las Vegas, Nevada, 89121
Glaucoma Consultants of Colorado
Littleton, Colorado, 80120
The Eye Care Institute Building
Louisville, Kentucky, 40206
The Center for Excellence in Eye Care
Miami, Florida, 33176
University of Minnesota
Minneapolis, Minnesota, 55404
Clayton Eye Center
Morrow, Georgia, 30260
Stiles Eyecare Excellence
Overland Park, Kansas, 66213
North Bay Eye Associates Inc
Petaluma, California, 94954
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Associates in Ophthalmology
Pittsburgh, Pennsylvania, 15122
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Ellison Ambulatory Care Center
Sacramento, California, 95817
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Harvard Eye Associates
San Clemente, California, 92673
Shepard Eye Center
Santa Maria, California, 93454
Glaucoma Consultants of Capital Region
Slingerlands, New York, 12159
International Eye Center
Tampa, Florida, 33603
James Branch MD
Winston-Salem, North Carolina, 27101
About this study
Official title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
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 open-angle glaucoma or ocular hypertension and co-existing cataract.
Read the detailed description
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 open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.
- Conditions
- Open-Angle Glaucoma
- Being tested
- iStent plus Cataract Surgery, Cataract surgery only
- 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.
iStent plus Cataract SurgeryDevice
Also called iStent Surgery
ab interno trabecular bypass stent surgery
Cataract surgery onlyProcedure or surgery
Also called Phacoemulsification
Cataract surgery only
| Study group | Role | What they receive |
|---|---|---|
| A--iStent plus Cataract Surgery | Active comparator | iStent plus Cataract Surgery Receives: Device: iStent plus Cataract Surgery |
| B--Cataract Surgery Only | Active comparator | Cataract Surgery only Receives: Procedure: Cataract surgery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months
Measured: 12 months
Secondary outcomes (1)
Efficacy
Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months
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 posted9 May 2006 (estimated)
- Study startJun 2005
- Primary completionJul 2009
- Study completionMar 2010
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Wells, PharmD, MBA, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323284
- Sponsor's protocol ID
- GC-003
- Status last verified
- Mar 2016
- First submitted
- 6 May 2006
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15.
PubMed 20828829Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025.
PubMed 22814041
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. 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
- NCT00323284
- Acronym / sponsor ID
- GC-003
- Conditions
- Open-Angle Glaucoma
- Keywords
- Open angle, Glaucoma, Cataract, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 4 Oct 2012
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 open-angle glaucoma or ocular hypertension and co-existing cataract.
Detailed description
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 open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A--iStent plus Cataract Surgery | Active comparator | Device: iStent plus Cataract SurgeryiStent plus Cataract Surgery |
| B--Cataract Surgery Only | Active comparator | Procedure: Cataract surgery onlyCataract Surgery only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
- Subject on at least one glaucoma medication
- Able and willing to attend follow up visits for two years post operative
- Able and willing to sign informed consent
Key exclusion criteria (3 listed)
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
- Angle closure glaucoma
- 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 |
|---|---|---|
| iStent plus Cataract SurgeryAlso: iStent Surgeryab interno trabecular bypass stent surgery | Device | A--iStent plus Cataract Surgery |
| Cataract surgery onlyAlso: PhacoemulsificationCataract surgery only | Procedure or surgery | B--Cataract Surgery Only |
Primary outcome
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
Time frame: 12 months
Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months
1 secondary outcome
Efficacy
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20828829Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15.
- Results publication: PubMed 22814041Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025.
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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.
Jeff Wells, PharmD, MBA study director
Glaukos Corporation
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iStent plus Cataract Surgery and Cataract surgery only in people with Open-Angle Glaucoma, run by Glaukos Corporation at 31 sites in United States.
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 3 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2012). 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?
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds (time frame: 12 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 NCT00323284, 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 Jan 2018.