Rhegmatogenous Retinal Detachment - Macula Off
Conditions
Keywords
retinal detachment repair, laser, air, photocoagulation, photodehydration, gas tamponade, rhegmatogenous retinal detachment, 1940nm, retinal thermofusion, medical device, iSeelr™
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. 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).
Interventions
DEVICEiSeelr™
The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear
Sponsors
Congressionally Directed Medical Research Programs
Photofuse Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
First in human use of investigational device called iSeelr™ system for the treatment of Rhegmatogenous Retinal Detachment
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 50 years or older. * Willing and able to comply with all study requirements and visits. * Provided written informed consent. Study Eye: * Recent onset as demonstrated by symptoms or diagnosis macular involving rhegmatogenous retinal detachment. * Detachment due to single or multiple retinal tears in the superior region of the retina Fellow eye: • Visual acuity of 6/12 or better.
Exclusion criteria
* History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation e.g. unstable diabetes, poorly controlled hypertension. * Travel limitations that could prevent review at proscribed study intervals or any other time during the study. * Inability to provide informed consent. * Anaesthetic risk factors or inability to lie supine for 1 hour. * Pregnant and/or breast feeding (to be confirmed on treatment day) * Current systemic infection * Current ocular infection * Unable to return for post-treatment visits * Known inability to attend the emergency department in the event of an adverse event.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and 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 | Number of participants with successful retinal reattachment as defined by absence of leakage at the tear margin within the first 48 hours post-treatment without the need for gas tamponade |
| Assessment of intra-operative and post-operative adverse events | Up to 90 days post treatment | To assess the safety of the treatment and the significance of any adverse events |
Countries
Australia
Contacts
Primary ContactPeter Keller
Outcome results
None listed