N/A
Completed N=505
Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Primary Open Angle Glaucoma (POAG) · Cataract
Source: ClinicalTrials.gov NCT01085357 ↗
Enrolled (actual)
505
Serious AEs
13.1%
Results posted
Oct 2016
Primary outcomePrimary: Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data — 72.5; 58.0 percentage of eyes
Summary
The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data |
72.5; 58.0 | — |
| SECONDARY Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data |
-7.0; -5.3 | — |
| SECONDARY Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data |
61.2; 43.5 | — |
Eligibility Criteria
Preoperative Inclusion Criteria:
- Diagnosis of primary open angle glaucoma (POAG)
- Mean diurnal unmedicated IOP of 21 - 33 mmHg
- Normal anterior chamber angle anatomy at site of implantation
- Operable age-related cataract
Exclusion Criteria
- Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
- Significant risk associated with washout of ocular hypotensive medication
- Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
- Previous corneal surgery
- Clinically significant ocular pathology, other than cataract and glaucoma
- Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
Data sourced from ClinicalTrials.gov (NCT01085357). 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.