NCT06468397

Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Photofuse Pty Ltd · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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. 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).

Conditions

• Rhegmatogenous Retinal Detachment - Macula Off

Interventions

Type	Name	Description
DEVICE	iSeelr™	The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear

Timeline

• Start date: 2024-09-13
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-06-21
• Last updated: 2026-01-14

Locations

1 site across 1 country: Australia