Condition category
Eye Diseases
Date applied
18/05/2010
Date assigned
17/06/2010
Last edited
17/06/2010
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-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 measures

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

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

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