Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01841437
• Collaborator: (none)
• Enrollment: 191
• Locations: 18
• Duration (Months): 33.6
• Patients Per Site: 10.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Device: iStent

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 191 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Feb 16, 2016
• Actual Study Completion Date: Jun 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
iStent	Device: iStent

Outcome Measures

Primary Outcome Measures

1. Rate of sight-threatening adverse events [36 months]

Secondary Outcome Measures

1. Other ocular adverse events [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

• Please refer to approved indications in Directions for Use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chico	California	United States	95926
2		Huntington Beach	California	United States	92647
3		Napa	California	United States	94558
4		Santa Maria	California	United States	93454
5		Ventura	California	United States	93003
6		Parker	Colorado	United States	80134
7		Portland	Maine	United States	04102
8		Quincy	Massachusetts	United States	02169
9		Bloomington	Minnesota	United States	55431
10		Westwood	New Jersey	United States	07675
11		Durham	North Carolina	United States	27710
12		Fayetteville	North Carolina	United States	28304
13		Southern Pines	North Carolina	United States	28387
14		Brecksville	Ohio	United States	44141
15		Youngstown	Ohio	United States	44502
16		Ladson	South Carolina	United States	29456
17		Sioux Falls	South Dakota	United States	57108
18		Appleton	Wisconsin	United States	54914

Sponsors and Collaborators

• Glaukos Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT01841437
• Other Study ID Numbers: GTS100-PAR
• First Posted: Apr 26, 2013
• Last Update Posted: Dec 18, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Glaukos Corporation: Primary open-angle glaucoma (POAG); Trabecular meshwork; iStent
• Additional relevant MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle

Study Results

No Results Posted as of Dec 18, 2017