SY: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Sponsor

Glaukos Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00911924

Collaborator

(none)

112

Enrollment

Locations

Arm

Duration (Months)

8.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Eye Diseases Glaucoma, Open-Angle	Device: iStent	Phase 4

Detailed Description

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iStent	Device: iStent Glaukos iStent, medication Other Names: stent, trabecular micro-bypass stent

Arm

Intervention/Treatment

Experimental: iStent

Device: iStent

Glaukos iStent, medication

Other Names:

stent, trabecular micro-bypass stent

Outcome Measures

Primary Outcome Measures

IOP 18 mm Hg or less without medications [At 6 months]
IOP 18 mm Hg or less with or without medications [12 months]

Secondary Outcome Measures

Mean IOP [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of primary open-angle glaucoma
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 at least 22 mm Hg and no greater than 38 mm Hg
Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

Angle closure glaucoma
Secondary glaucomas
Prior glaucoma procedures
Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	S.V. Malayan's Ophtalmology Centre	Yerevan	Armenia	375108
2	Allgemeines Krankenhaus Wien	Wien	Austria	1090
3	Chu de Lyon Hospital Edouard Herriot	Lyon	France	69437
4	CHNO des Quinze-Vingts	Paris	France	75012
5	Hopital Saint-Joseph	Paris	France	75014
6	Knapschaftskrankenhaus Bochum Langendreer	Bochum	Germany	44892
7	Universitatsklinkum Erlangen	Erlangen	Germany
8	Universitatsklinikum Magdeburg A.o.R.	Magdeburg	Germany	39120
9	Dietrich-Bonhoeffer-Klinikum Neubrandenburg	Neubrandenburg	Germany	17036
10	Universita' degli Studi di Parma	Parma	Italy	43100
11	Universita'di Torino	Torino	Italy	10128
12	Hospital clinico San Carlos	Madrid	Spain	28040
13	Hospital Torrevieja Salud, UTE	Torrevieja	Spain	03186