Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
NCT ID: NCT00913029
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
192 participants
INTERVENTIONAL
2009-05-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
NCT00911924
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
NCT03478293
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
NCT01252914
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
NCT00326040
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2
NCT00326079
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stent
One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
iStent
iStent
Medication
One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.
latanoprost/timolol
Combination latanoprost/timolol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iStent
iStent
latanoprost/timolol
Combination latanoprost/timolol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female at least 18 years of age and able to provide written informed consent
* Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
* Likely to be available and willing to attend follow-up visits
Exclusion Criteria
* Secondary glaucomas
* Prior glaucoma procedures
* Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glaukos Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeff Wells, PharmD, MBA
Role: STUDY_DIRECTOR
Glaukos Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SV Malayan Ophthalmological Center
Yerevan, , Armenia
Allgemeines Krankenhaus Wien
Vienna, , Austria
CHU de Lyon Hopital Edouard Herriot
Lyon, , France
CHNO des Quinze-Vingts
Paris, , France
Knapschaftskrankenhaus Bochum Langendreer
Bochum, , Germany
Helios Cliniic
Erfurt, , Germany
Universitatsklinkum Erlangen
Erlangen, , Germany
AHEPA Hospital
Thessaloniki, , Greece
Universita'degli Studi di Parma
Parma, , Italy
Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
Torino, , Italy
Azienda Ospedaliera S. Maria della Misericordia
Udine, , Italy
Military Health Service Institute
Warsaw, , Poland
Hospital Torrevieja Salud, UTE
Alicante, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Hinchingbrooke Hospital Moorfields
Bedford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Second Line Trial
Identifier Type: OTHER
Identifier Source: secondary_id
Second Line
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.