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

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Eye Diseases; Glaucoma
• Interventions: Device: iStent

• Registration Number: NCT00911924
• Lead Sponsor: Glaukos Corporation

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.

Detailed Description

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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iStent	iStent	-

Primary Outcome Measures

Name	Time	Method
IOP 18 mm Hg or less with or without medications	12 months
IOP 18 mm Hg or less without medications	At 6 months

Secondary Outcome Measures

Name	Time	Method
Mean IOP	12 months

Trial Locations

Locations (13)

Allgemeines Krankenhaus Wien; 🇦🇹 Wien, Austria

Knapschaftskrankenhaus Bochum Langendreer; 🇩🇪 Bochum, Germany

Hopital Saint-Joseph; 🇫🇷 Paris, France

Universitatsklinikum Magdeburg A.o.R.; 🇩🇪 Magdeburg, Germany

Universita' degli Studi di Parma; 🇮🇹 Parma, Italy

Universitatsklinkum Erlangen; 🇩🇪 Erlangen, Germany

Universita'di Torino; 🇮🇹 Torino, Italy

Hospital clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Torrevieja Salud, UTE; 🇪🇸 Torrevieja, Spain

Chu de Lyon Hospital Edouard Herriot; 🇫🇷 Lyon, France

CHNO des Quinze-Vingts; 🇫🇷 Paris, France

Dietrich-Bonhoeffer-Klinikum Neubrandenburg; 🇩🇪 Neubrandenburg, Germany

S.V. Malayan's Ophtalmology Centre; 🇦🇲 Yerevan, Armenia