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
- Aged 50 years or older.
- Willing and able to comply with all study requirements and visits.
- Provided written informed consent.
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.
- Significant vitreous haemorrhage partially or fully obscuring detailed examination of the retina
- Intraoperative identification of tears below the superior 4 clock hours in the area of retinal detachment 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)
- Myopia greater than 3 D spherical equivalent as confirmed by last refraction prior to becoming pseudophakic if cataract surgery has been performed
- History of glaucoma or elevated intraocular pressure >21mmHg
- Prior or current intraocular infection
- Visual Acuity worse than 6/12
- Myopia greater than -3D spherical equivalent or axial length greater than 26mm if known
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06468397
Intervention or treatment
DEVICE: iSeelr™
Conditions
- Rhegmatogenous Retinal Detachment - Macula Off
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
The Royal Victorian Eye and Ear Hospital (RVEEH)
Select from list below to view details:
The Royal Victorian Eye and Ear Hospital (RVEEH)
East Melbourne, Victoria, Australia
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Who is running the clinical trial?
Photofuse Pty Ltd
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
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments. | 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 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
References
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