CyCLE: CyPass Clinical Experience Study

Sponsor

Transcend Medical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01097174

Collaborator

(none)

555

Enrollment

Locations

Duration (Months)

39.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass Micro-Stent in patients with glaucoma.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma (OAG)	Device: CyPass Micro-Stent

Study Design

Study Type:

Observational

Actual Enrollment :

555 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

A Multicenter Registry Study to Capture Data With Respect to CyPass Clinical Experience

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
CyPass Micro-stent Patients in whom CyPass Micro-stent implantation was attempted.	Device: CyPass Micro-Stent The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.

Arm

Intervention/Treatment

CyPass Micro-stent

Patients in whom CyPass Micro-stent implantation was attempted.

Device: CyPass Micro-Stent

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.

Outcome Measures

Primary Outcome Measures

Incidence of intraoperative and postoperative adverse events [Day 0 - Year 3]

Secondary Outcome Measures

Intraocular pressure (IOP) reduction [1 - 36 months postoperatively]
Ocular hypotensive medication use [1 - 36 months postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of OAG
IOP ≥ 21 mmHg and ≤ 31 mmHg (with or without ocular hypotensive medication)

Exclusion Criteria:

Acute angle closure, narrow angle, uveitic or neovascular glaucoma
Normal tension glaucoma

Contacts and Locations

Locations

	Site	City	Country
1	University Eye Clinic	Salzburg	Austria
2	Specialized Hospital for Active Treatment of Ophthalmologic Diseases	Sofia	Bulgaria
3	Schlosspark-Klinik, Department of Ophthalmology	Berlin	Germany
4	Knappschaftskrankenhaus Bochum-Langendreer	Bochum	Germany
5	AugenKlinik Cham	Cham	Germany
6	Klinik fur Augenheilkunde, Campus Lubeck	Lubeck	Germany
7	Klinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum	Neubrandenburg	Germany
8	Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazio	Catania	Italy
9	Wojskowy Instytut Medyczny (Military Medical Institute)	Warsaw	Poland
10	Institut Catala de Retina	Barcelona	Spain
11	Instituto de Microcirugia Ocular	Barcelona	Spain
12	Hospital Clinico San Carlos	Madrid	Spain
13	Ramón y Cajal University Hospital	Madrid	Spain
14	Hospital Universiatrio Miguel Servet	Zaragoza	Spain