Primary open angle glaucoma, ocular hypertension Eye Diseases Glaucoma
Conditions
Interventions
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 w
Sponsors
Transcend Medical, Inc.™ (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at 12 months: 1. Best corrected visual acuity 2. Intraocular pressure (IOP) 3. Manifest refraction 4. Biomicropscopy 5. Gonioscopy 6. Ophthalmoscopy (dilated) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Malaysia, Mexico, Philippines
Outcome results
None listed