Safety and efficacy of Transcend CyPass glaucoma implant in open angle glaucoma patients who have failed medical treatment
ISRCTN | ISRCTN23263504 |
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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
Scientific
Transcend Medical
20 Pacifica, Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com |
Study information
Study design | Open-label prospective study |
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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 |
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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
92618
United States of America
Sponsor information
Transcend Medical, Inc.™ (USA)
Industry
Industry
c/o Ginger Clasby
20 Pacifica, Suite 220
Irvine
92618
United States of America
gclasby@transcendmedical.com | |
Website | http://www.transcendmedical.com/index.htm |
https://ror.org/028fhxy95 |
Funders
Funder type
Industry
Transcend Medical, Inc.™ (USA)
No information available
Results and Publications
Intention to publish date | |
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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 |