|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01085357 |
|
Date of registration:
|
01/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
COMPASS |
|
Scientific title:
|
A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery |
|
Date of first enrolment:
|
September 2009 |
|
Target sample size:
|
723 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01085357 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Ginger Clasby |
|
Address:
|
|
|
Telephone:
|
949-379-1962 |
|
Email:
|
|
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion 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
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cataract
|
|
Primary Open Angle Glaucoma (POAG)
|
|
Intervention(s)
|
|
Device: CyPass Micro-stent
|
|
Procedure: Cataract Surgery
|
|
Primary Outcome(s)
|
|
Proportion of eyes with = 20% decrease in intraocular pressure (IOP) from baseline to the hypotensive medication-free 24-month postoperative examination
[Time Frame: 24 months postoperative]
|
|
Secondary Outcome(s)
|
|
Mean change in IOP between baseline and hypotensive medication-free 24-month postoperative examination
[Time Frame: 24 months postoperative]
|
|
Proportion of eyes with postoperative IOP = 6 and = 18 mmHg, as measured by Goldmann Tonometry, at the hypotensive medication-free 24-month postoperative examination
[Time Frame: 24 months postoperative]
|
|
Secondary ID(s)
|
|
TMI-09-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|