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-07-01
Study information
Scientific title
A pilot study to assess the safety and efficacy of the Transcend CyPass glaucoma implant in patients with open angle glaucoma who have failed medical treatment
Acronym
Study hypothesis
The objective of the study is to evaluate the safety and effectiveness of the Transcend CyPass implant in patients with primary open-angle glaucoma (POAG) who have failed intraocular pressure (IOP) management on maximally tolerated medication.
Ethics approval
Western Institutional Review Board (WIRB) approved on the 20th April 2008
Study design
Open-label prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary open angle glaucoma
Intervention
Transcend CyPass implant used to treat primary open-angle glaucoma. The patients will be followed for 12 months following surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Efficacy will be evaluated as change in IOP from the pre-operative baseline, absolute and relative, proportion of patients with an IOP of 21 mmHg or less, and change in the number of glaucoma medications. This will be done based on the 3 month visit results. Subsequent data (6 months and 12 months) will be collected as confirmatory.
Secondary outcome measures
Safety will be evaluated by ocular signs and symptoms, (best corrected) visual acuity, biomicroscopy, ophthalmoscopy and gonioscopy, as well as by adverse events. Progression of glaucomatous field defects will also be a safety measure (see analysis of visual field progression).
All measured at 12 months.
Overall trial start date
20/08/2008
Overall trial end date
20/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males or females 18 years of age or older
2. Diagnosis in the study eye of primary open angle glaucoma (POAG) or open angle glaucoma associated with pseudoexfoliation syndrome or pigmentary glaucoma
3. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits
4. Intra-ocular pressure (IOP) of greater than or equal to 21 mmHg and less than or equal to 40 mmHg while on maximal tolerated medical therapy, documented at two sequential visits at any time of day, at least 48 hours apart, within 45 days prior to surgery
5. Patients must sign and witness the current Informed Consent Document
6. Patients must have sufficient space of the angle to accommodate the device
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 patients
Participant exclusion criteria
1. Visual acuity of light perception or less in the study eye
2. Any previous surgery for any aqueous shunt device
3. Prior laser treatment of the retina
4. Any ophthalmic surgery performed within three months prior to study
5. Diagnosis of angle closure following penetrating keratoplasty, neovascular glaucoma, congenital glaucoma, developmental glaucoma, previous goniotomy, "active" uveitis within six months, or other secondary glaucomas (except pseudoexfoliation syndrome or pigmentary glaucoma, which are allowed)
6. Best corrected visual acuity (BCVA) less than 20/200 in the fellow eye
7. Active diabetic retinopathy
8. Clinically significant inflammation or infection within six months prior to study
9. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
10. Participation in any study involving an investigational drug within the past 45 calendar days, or ongoing participation in a study with an investigational device
11. Intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device
12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
14. Female patients of childbearing potential less than 1 year postmenopausal, and not surgically sterilised, who are not on a medically-acceptable form of birth control
Recruitment start date
20/08/2008
Recruitment end date
20/08/2009
Locations
Countries of recruitment
Canada
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
Basic results (scientific)
Publication list