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

Completed

• Conditions: Primary open angle glaucoma; Eye Diseases; Glaucoma

• Registration Number: ISRCTN23263504
• Lead Sponsor: Transcend Medical, Inc.™ (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).<br><br>All measured at 12 months.