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

Photofuse Pty Ltd

Status

Not yet enrolling

Conditions

Rhegmatogenous Retinal Detachment - Macula Off

Treatments

Device: iSeelr™

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT06468397

RTF-CIP-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

10 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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 4 clock hours
Pseudophakia

Fellow eye:

• Best Corrected Visual acuity (BCVA) 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

Exclusion criteria in the study eye:

Significant vitreous haemorrhage partially or fully obscuring detailed examination of the retina
Intraoperative identification of tears beyond the superior 4 clock hours not identified at the screening visit or during pre-operative examination
Clinical signs of PVR (+1 flare, vitreous clumps, pigment clusters on the inferior retina, rolled retinal tear edge, star-fold)
Phakic
Myopia greater than 3 D spherical equivalent as confirmed by last refraction prior to becoming pseudophakic, and/or
History of glaucoma or elevated intraocular pressure >21
Prior or current intraocular infection Unable to return for post-treatment visits
Known inability to attend the emergency department in the event of an adverse event.

Exclusion criteria in the fellow eye:

Best corrected Visual Acuity (BCVA) worse than 6/12
Axial length greater than 26mm
Any potential sight threatening pathology in the fellow eye as determined by the investigator.
Extensive lattice degeneration,
Unilateral high myopia as determined by the investigator,
family history of retinal detachment,
collagen disorders such as Marfan's or Sticklers syndrome.
History of ocular trauma
Evidence of any abnormality of the eye structure as determined by the investigator
Planned surgery during the study period