Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477685
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2007-05-23
Brief Title:
Ologen OculusGen-Phacotrabeculectomy Historical Control Study in India
Sponsor:
Pro Top Mediking Company Limited
Organization:
Pro Top Mediking Company Limited
Study Overview
Official Title:
Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery
Status:
COMPLETED
Status Verified Date:
2017-07
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:
1 Study Objective The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure 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 a historical controlled study Patient who meet the inclusionexclusion criteria and sign the informed consent form will be included for this study The allocation of subjects is non-randomized and there is a single group for assignment
3 Follow-Up This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery Patients should be seen at postoperative days 1 7 14 30 60 90 and 180 The visit window of 7 days is allowed for the 30 60 90 and 180 day visits The further follow-up of subject after trial is continually tracked by the investigator
2 Study Design The study is designed as a historical controlled study Patient who meet the inclusionexclusion criteria and sign the informed consent form will be included for this study The allocation of subjects is non-randomized and there is a single group for assignment
3 Follow-Up This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery Patients should be seen at postoperative days 1 7 14 30 60 90 and 180 The visit window of 7 days is allowed for the 30 60 90 and 180 day visits The further follow-up of subject after trial is continually tracked by the investigator
Detailed Description:
ologen collagen matrix is applied for the phacotrabec 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OculusGen-2007-04-20 | OTHER | Aeon Astron Europe BV | None |