Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273221
Status:
UNKNOWN
Last Update Posted:
2008-05-22
First Post:
2006-01-06
Brief Title:
Combined Phacotube vs PhacotrabeculectomyA Randomized Controlled Trial
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
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:
The aim of this study is to compare the effectiveness and safety of combined phacoemulsification posterior chamber intraocular lens implantation trabeculectomy phacotrabeculectomy with phacoemulsification intraocular lens implantation and glaucoma drainage devicephacotube in the early and intermediate control of intraocular pressureIOP in patients with primary open angle and angle closure glaucoma
Detailed Description:
Studies have pointed out racial differences in the outcome of conventional filtration surgery Glaucoma drainage implants have been found to do well in Asian eyes but no randomized controlled trial is available to support this claim Objectives It is the aim of this study to compare the effectiveness and safety of combined phacoemulsification posterior chamber intraocular lens implantation trabeculectomy phacotrabeculectomy versus phacoemulsification intraocular lens implantation and glaucoma drainage devicephacotube in the early and intermediate control of intraocular pressureIOP in patients with primary open angle and angle closure glaucoma The secondary objective is to look into the post-operative complications encountered in phacotrabeculectomy and phacotube including the additional interventions laser suture lysis bleb needling antimetabolite injections etc applied in both procedures being studied Study Design Randomized controlled trial Methods A total of 50 Asian subjects 21 years old and above diagnosed with primary openangle closure glaucoma inadequately controlled by laser and medical treatment with significant cataract and no previous eye surgery will be randomized to two types of combined procedures phacotrabeculectomy and phacotube Primary outcome measure is intraocular pressure and secondary outcome measures will be visual acuity anterior chamber depth visual field stability or progression glaucoma medication requirement operative and post-operative complications and additional secondary interventionseg laser suture lysis bleb needling 5-FU injections anterior chamber reformation All subjects will be followed up for a period of 1 yearThis trial may define the role of GDI as a primary surgical option for Asian patients and the first randomized clinical trial in Asia to compare two combined procedures for glaucoma and cataract namely phacotrabeculectomy and phaco-glaucoma drainage implant surgery
Study Oversight
Has Oversight DMC:
None
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?:
None