Contact information
Type
Scientific
Primary contact
Mrs Ginger Clasby
ORCID ID
Contact details
Transcend Medical
20 Pacifica
Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TMI-09-02
Study information
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
Acronym
Study hypothesis
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
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
Study design
Multicentre registry study with retrospective and/or prospective data capture
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
15/12/2009
Overall trial end date
15/12/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Up to 500 subject eyes enrolled at up to 20 study sites
Participant 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
Recruitment start date
15/12/2009
Recruitment end date
15/12/2011
Locations
Countries of recruitment
Bulgaria, Germany, Italy, Poland, Spain
Trial participating centre
Transcend Medical
Irvine
92618
United States of America
Sponsor information
Organisation
Transcend Medical, Inc.™ (USA)
Sponsor details
c/o Ginger Clasby
20 Pacifica
Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Transcend Medical, Inc.™ (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary