Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-27
Brief Title:
Acute Retinal Detachment Repair With the iSeelr Retinal Detachment Repair System
Sponsor:
Photofuse Pty Ltd
Organization:
Photofuse Pty Ltd
Study Overview
Official Title:
An Improved Retinal Detachment Repair Method A First-in-human Clinical Trial of the Safety and Performance of the iSeelr Retinal Detachment Repair System to Seal Retinal Tears Intraoperatively
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study is a first-in-human clinical trial testing a new treatment for rhegmatogenous retinal detachments The new treatment called retinal thermofusion uses a special laser device called iSeelr during surgery The benefit of the device is that it repairs retinal tears without needing a gas bubble making it quicker to recover from surgery The study will help us determine how safe and well the device performs in repairing a retinal detachment in people
Detailed Description:
The retina is a light-sensitive layer at the back of your eye that captures images When light enters your eye the retina turns it into signals that travel to your brain helping you see Its crucial for clear vision When a retinal tear forms at the back of your eye it can cause the fluid inside your eye to leak leading to the retina peeling away and cause vision problems including blindness
Retinal Thermofusion RTF uses a laser device called iSeelr to first dehydrate the fluid buildup around the retina and then laser treatment to seal the retina back in its place The device was developed by Photofuse Pty Ltd and method validated in a laboratory with the Centre for Eye Research Australia and The University of Melbourne Victoria AustraliaThis clinical trial involves recruiting 10 participants with rhegmatogenous retinal detachment who will receive the treatment and be closely followed with 7 study visits over a three month period This will allow us to assess the safety and performance of RTF This research is being Sponsored by Photofuse Pty Ltd and is funded by the US Department of Defense Award W81XWH-21-1-0730
Retinal Thermofusion RTF uses a laser device called iSeelr to first dehydrate the fluid buildup around the retina and then laser treatment to seal the retina back in its place The device was developed by Photofuse Pty Ltd and method validated in a laboratory with the Centre for Eye Research Australia and The University of Melbourne Victoria AustraliaThis clinical trial involves recruiting 10 participants with rhegmatogenous retinal detachment who will receive the treatment and be closely followed with 7 study visits over a three month period This will allow us to assess the safety and performance of RTF This research is being Sponsored by Photofuse Pty Ltd and is funded by the US Department of Defense Award W81XWH-21-1-0730
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None