N/A
Completed N=142
Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma
Source: ClinicalTrials.gov NCT02448875 ↗Enrolled (actual)
142
Serious AEs
7.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication — 63.0; 83.3; 73.5 percentage of subjects
Summary
The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication |
63.0; 83.3; 73.5 | — |
| SECONDARY Percentage of Subjects With Device-related Ocular Adverse Events |
1.7; 4.8; 4.9; 58.3; 71.4; 63.9 | — |
| SECONDARY Mean Change From Baseline to 12 Months Postoperative in Medicated IOP |
21.08; 22.17; 21.71; -4.29; -4.00; -4.81 | — |
| SECONDARY Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months |
37.5; 42.9; 36.1 | — |
| SECONDARY Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used |
-0.8; -0.3; -0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of open angle glaucoma;
- Unmedicated IOP between 21 - 36 mmHg, inclusive;
- Normal angle anatomy at site of intended CyPass Micro-Stent implantation.
Exclusion Criteria
- Advanced glaucoma;
- Prior incisional glaucoma surgery;
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
- Clinically significant ocular pathology other than glaucoma.
Data sourced from ClinicalTrials.gov (NCT02448875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.