Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448929
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2007-03-15
Brief Title:
Ologen OculusGen-Glaucoma Case Control Trial in India
Sponsor:
Pro Top Mediking Company Limited
Organization:
Pro Top Mediking Company Limited
Study Overview
Official Title:
Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen OculusGen Collagen Matrix Implant
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
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 purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen OculusGen Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents
Detailed Description:
1 Study Objective To determine the safety and effectiveness of the ologen OculusGen Biodegradable Collagen Matrix Implant in filtration surgery The primary endpoint is to prove the effectiveness via the reduction of IOP and the secondary endpoint is to prove the safety via the incidence of complications and adverse events
2 Study Design The study is designed as an open-label randomized parallel comparative study Patients who meet the inclusionexclusion criteria and sign informed consent will be included After enrollment patients will be randomized into two groups trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics
3 Follow-Up There will be 7 post-operative and follow-up visits within 6 months of surgery postoperative days 1 7 14 30 60 90 and 180 A window of 7 days is allowed for the 30 60 90 day visits and 14 days for the 180 day visits Further follow-up of subjects after the trial will be the responsibility of the investigator
2 Study Design The study is designed as an open-label randomized parallel comparative study Patients who meet the inclusionexclusion criteria and sign informed consent will be included After enrollment patients will be randomized into two groups trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics
3 Follow-Up There will be 7 post-operative and follow-up visits within 6 months of surgery postoperative days 1 7 14 30 60 90 and 180 A window of 7 days is allowed for the 30 60 90 day visits and 14 days for the 180 day visits Further follow-up of subjects after the trial will be the responsibility of the investigator
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OculusGen-2006-03-20 | None | None | None |