Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT00326014
  4. Details
NCT00326014 Clinical Trial

A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Open-Angle Glaucoma Clinical Trial

Official title:
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00326014
Other study ID # GC-002
Secondary ID
Status Completed
Phase Phase 4
First received May 12, 2006
Last updated June 3, 2015
Start date April 2003
Est. completion date December 2009

Study information
Verified date June 2015
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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.

Description:

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date December 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with primary open-angle glaucoma (POAG)

- Subject on at least one glaucoma medication

- Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria:

- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)

- Angle closure glaucoma

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• iStent
Glaucoma Surgery

Locations
Country Name City State
Germany Klinik Vincentinum Augsburg
Germany Universitats Augenklinik Freiburg
Germany Rotkreuz Krankenhaus München
Germany Klinikum Neubrandenburg Neubrandenburg
Germany Augenaerztliche Gemeinschaftspraxis Weinheim
Spain Clinico San Carlos Madrid
Spain Instituto Oftalmológico de Aragón Zaragoza
Switzerland Augenklinik Kantonsspital Winterthur

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

References & Publications (2)

Spiegel D, García-Feijoó J, García-Sánchez 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy 24 months No
See also
  Status Clinical Trial Phase
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT01456390 - Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents N/A
Completed NCT01487655 - Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients N/A
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4
Completed NCT01444105 - Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty N/A
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01455467 - Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery N/A
Completed NCT01443988 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost Phase 4
Completed NCT01444040 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Phase 4
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT00759239 - Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT00397241 - 24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations Phase 4
Completed NCT00273481 - Cosopt Versus Xalacom Phase 4
Completed NCT00918346 - Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation Phase 3
Completed NCT00716742 - Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG) N/A
Completed NCT02558400 - Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Withdrawn NCT03648229 - African Glaucoma Laser Trial Phase 4
Completed NCT01978600 - Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT01699464 - A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months Phase 2