Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-01 @ 8:46 AM
Study NCT ID:
NCT02209961
Status:
UNKNOWN
Last Update Posted:
2014-08-06
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Sponsor:
Hillel Yaffe Medical Center
Organization:
Study Overview
Official Title:
To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.
Detailed Description:
The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.
Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.
The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.
This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .
Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.
The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.
This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: