Condition category
Eye Diseases
Date applied
18/05/2010
Date assigned
17/06/2010
Last edited
07/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.transcendmedical.com/index.htm

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

Publication citations

Additional files

Editorial Notes