Transcend CyPass glaucoma implant and cataract surgery in open angle glaucoma patients
| ISRCTN | ISRCTN86839890 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86839890 |
| Protocol serial number | TMI-08-01C |
| Sponsor | Transcend Medical, Inc.™ (USA) |
| Funder | Transcend Medical, Inc.™ (USA) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open-label controlled prospective pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot study to assess the safety and efficacy of the Transcend CyPass glaucoma implant in combination with cataract surgery in patients with open angle glaucoma |
| Study objectives | The objectives of the study are to evaluate the safety and effectiveness of the Transcend CyPass implant in combination with cataract surgery in patients with primary open-angle glaucoma (POAG). |
| Ethics approval(s) | No ethics approval required as this was a prospective registry study with no interventions. |
| Health condition(s) or problem(s) studied | Primary open angle glaucoma, ocular hypertension |
| Intervention | Group 1: eyes will undergo both cataract surgery and CyPass implantation and patients will be followed for 12 months following surgery. Group 2: eyes will undergo only cataract surgery and patients will be followed for 12 months following surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured at 12 months: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Patients must be age 18 or over, either sex 2. Patients must have diagnosis of primary open angle glaucoma or ocular hypertension (OHT). Also acceptable are patients diagnosed with open angle glaucoma associated with pseudoexfoliation syndrome or pigmentary glaucoma. 3. Candidacy for cataract surgery in the study eye as determined by the clinical judgment of the investigator 4. Patients who have had previous trabeculoplasty glaucoma procedures such as argon laser trabeculoplasty (ALT) or selective laser trabeculoplasty (SLT) 5. Patients must have intraocular 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 30 days prior to surgery 6. Patients must have sufficient space in the angle to accommodate the device 7. Patients must be able to understand the requirements of the study and be 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 |
| Key exclusion criteria | 1. Patients with previous glaucoma surgery, including trabeculectomy or implantation of any aqueous shunt device, or the following glaucoma surgeries: viscocanulostomy, cyclophotocoagulation, or collagen implant 2. Patients with any ophthalmic surgery within 3 months in the eye to be treated 3. Patients with diagnosis of angle closure following penetrating keratoplasty, neovascular glaucoma, congenital glaucoma, developmental glaucoma or previous goniotomy 4. Patients with active uveitis within six months or other secondary glaucomas (other than pseudoexfoliation syndrome or pigmentary glaucoma) 5. Patients with best corrected visual acuity less than 20/200 in the fellow eye 6. Patients with clinically significant inflammation or infection within 6 months prior to the study 7. Patients with active diabetic retinopathy 8. Patients who have any uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the investigator 9. Intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device 10. A medical condition, serious illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up 11. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient 12. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device 13. Patients who are pregnant or planning to be pregnant during the course of the study |
| Date of first enrolment | 30/04/2008 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- Malaysia
- Mexico
- Philippines
- United States of America
Study participating centre
Transcend Medical
Irvine
92618
United States of America
92618
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
