Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Open-angle Glaucoma Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721968
• Other study ID #: GC-005
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2008
• Last updated: February 4, 2014
• Start date: March 2007
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.

Description:

The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery

• Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

Not meeting inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma, Open-Angle
• Open-angle Glaucoma

Intervention

Device:
• Glaucoma Stent Surgery (GTS400 Stent)
ab interno trabecular bypass stent surgery

Procedure:
• cataract surgery alone
Cataract surgery alone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Ocular Hypotensive Medications by Visit		12 months	No
Primary	Month 12 Intraocular Pressure = 18 mmHg Without Topical Hypotensive Medications	Percent reaching this endpoint	12 months	No