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Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
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.
Study details:
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. It's 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, Australia.
This 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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 50 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-31
Primary completion: 2025-03-01
Study completion finish: 2025-06-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT06468397
Intervention or treatment
DEVICE: iSeelr™
Conditions
- • Rhegmatogenous Retinal Detachment - Macula Off
Find a site
Closest Location:
The Royal Victorian Eye and Ear Hospital (RVEEH)
Research sites nearby
Select from list below to view details:
The Royal Victorian Eye and Ear Hospital (RVEEH)
East Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Retinal Thermofusion
| DEVICE: iSeelr™
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Number of participants with successful retinal reattachment without the need for gas tamponade | To assess the performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments. | Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment |
| Assessment of intra-operative and post-operative adverse events | To assess the safety of the treatment and the significance of any adverse events | Up to 90 days post treatment |
Secondary outcome
Frequently Asked Questions
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