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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN23263504
• Date of registration: 17/06/2010
• Primary sponsor: Transcend Medical, Inc.™ (USA)
• Public title: Safety and efficacy of Transcend CyPass glaucoma implant in open angle glaucoma patients who have failed medical treatment N/A
• 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
• Date of first enrolment: Aug 20 2008
• Target sample size: 20 patients
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN23263504
• Study type: Interventional
• Study design: Open-label prospective study

Countries of recruitment

Canada

Contacts

• Name: Ginger Clasby

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Primary open angle glaucoma

Intervention(s)

Transcend CyPass implant used to treat primary open-angle glaucoma. The patients will be followed for 12 months following surgery.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

TMI-07-01

Source(s) of Monetary Support

Transcend Medical, Inc.™ (USA)

Secondary Sponsor(s)

N/A