Safety and efficacy of Transcend CyPass glaucoma implant in open angle glaucoma patients who have failed medical treatment

ISRCTN	ISRCTN23263504
DOI	https://doi.org/10.1186/ISRCTN23263504
Secondary identifying numbers	TMI-07-01

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

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	Open-label prospective study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Western Institutional Review Board (WIRB) approved on the 20th April 2008
Health condition(s) or problem(s) studied	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
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 study start date	20/08/2008
Completion date	20/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20 patients
Key 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
Key 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
Date of first enrolment	20/08/2008
Date of final enrolment	20/08/2009

Locations

Countries of recruitment

Canada
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