Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ivantis, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is a prospective evaluation of the Hydrus Microstent for the treatment of Primary Angle Closure (PAC) and Primary Angle Closure Glaucoma (PACG) with adjunctive cataract. A total of 20 subjects will be successfully treated with one Hydrus device after completion of cataract extraction with phacoemulsification followed by IOL replacement (HMS cohort), and 10 eyes will be treated with phacoemulsification cataract extraction and IOL replacement only (PCS group). Since cataract surgery is standard of care for this condition, eligible fellow eyes from the HMS cohort may be enrolled into the PCS group. To avoid selection bias in this non-randomized study, the first 20 consecutive qualifying subjects will be treated with Hydrus and the next 10 consecutive qualifying eyes will be treated with cataract surgery only.
The objective of this study is to assess the effectiveness of the Hydrus Microstent for lowering intraocular pressure in patients with PAC or PACG. The addition of the Hydrus is expected to lower IOP and medication dependency, and thus reduce the risk of progression of glaucoma. The PCS group will provide a control group to assess the magnitude of the Hydrus treatment effect on IOP, medications, and safety.
Upon successfully meeting the study inclusion/exclusion criteria at both the screening and baseline visits, the subject will be scheduled for surgery. Follow up will be continued for 1 year post surgery, and will include assessments of the subject's IOP, ocular health, and visual acuity status. Visits will be conducted at 1, 7, 30, 90, 180, and 365 days.
A 20% drop in IOP in response to therapy is considered clinically meaningful. The study treatment will be considered successful if a patient can obtain this response in IOP using the same or a fewer number of medications as pre-operative baseline.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Cataract extraction and intraocular lens placement with combined placement of glaucoma microstent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabecular bypass and Schlemm's canal stent | Device | ab interno Microstent placement after cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in IOP | Proportion of subjects with > or = 20% reduction of IOP while maintaining the same or fewer number of glaucoma medications compared with baseline, measured by Goldmann applanation tonometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP | Change in IOP compared to baseline IOP regardless of the number of glaucoma medications | 12 months |
Not provided
Inclusion Criteria:
Pre-Operative Inclusion Criteria
The subject is able to understand the requirements of the study and is willing to provide written informed consent, follow study instructions, and comply with all study procedures.
Intraoperative Inclusion Critera
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Eye Institute | Makati City | National Capital Region | 1200 | Philippines |
Not provided
| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided