A multicentre registry study to capture data with respect to CyPass clinical experience (CYCLE)

ISRCTN	ISRCTN74288501
DOI	https://doi.org/10.1186/ISRCTN74288501
Secondary identifying numbers	TMI-09-02

Submission date: 18/05/2010
Registration date: 17/06/2010
Last edited: 07/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Ginger Clasby
Scientific

Transcend Medical
20 Pacifica, Suite 220
Irvine
92618
United States of America

Email	gclasby@transcendmedical.com

Study information

Study design	Multicentre registry study with retrospective and/or prospective data capture
Primary study design	Interventional
Secondary study design	Multi-centre
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Long-term safety, effectiveness and clinical experience of the CyPass glaucoma implant when used in the standard clinical environment: a multicentre registry study with retrospective and/or prospective data capture
Study objectives	The purpose of this research study is to evaluate the long-term safety, effectiveness and clinical experience of the CyPass implant in glaucomatous eyes when used in accordance with the product instructions for use (IFU) in the standard clinical environment.
Ethics approval(s)	1. Germany: 1.1. FEKI approved on the 15th December 2009 1.2. Ruhr University approved on the 19th February 2009 1.3. Universitat Greifswald approved on the 27th January 2010 2. Poland: Ethics Committee at Military Medical Institute approved on the 21st April 2010
Health condition(s) or problem(s) studied	Glaucoma
Intervention	The total duration of the treatments was 12 months. Observations and assessments included best corrected visual acuity (BCVA, Snellen), tonometry, slit lamp exam and adverse event assessment.
Intervention type	Other
Primary outcome measure	Safety outcomes: Incidence of intra-operative and post-operative adverse events
Secondary outcome measures	Effectiveness Outcomes: 1. Mean change in IOP from baseline to 1 month post-operatively, and beyond 2. Mean change in required glaucoma medications used from baseline to 1 month post-operatively, and beyond
Overall study start date	15/12/2009
Completion date	15/12/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Up to 500 subject eyes enrolled at up to 20 study sites
Key inclusion criteria	1. Able to understand study requirements and willing to follow study instructions and provide written consent 2. Diagnosis of glaucoma in the study eye 3. At the preoperative visit, a mean medicated or unmedicated intraocular pressure (IOP) in the study eye of greater than or equal to 18 mmHg and less than or equal to 44 mmHg
Key exclusion criteria	1. Diagnosis of acute angle closure, narrow angle, uveitic or neovascular glaucoma in the study eye 2. Diagnosis of normal tension glaucoma in the study eye
Date of first enrolment	15/12/2009
Date of final enrolment	15/12/2011

Locations

Countries of recruitment

Bulgaria
Germany
Italy
Poland
Spain
United States of America

Study participating centre

Transcend Medical

Irvine
92618
United States of America

Sponsor information

Transcend Medical, Inc.™ (USA)
Industry

c/o Ginger Clasby
20 Pacifica, Suite 220
Irvine
92618
United States of America

Email	gclasby@transcendmedical.com
Website	http://www.transcendmedical.com/index.htm
"ROR"	https://ror.org/028fhxy95

Funders

Funder type

Industry

Transcend Medical, Inc.™ (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan