Actively Recruiting
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
Led by Photofuse Pty Ltd · Updated on 2026-01-14
10
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
P
Photofuse Pty Ltd
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years or older.
- Willing and able to comply with all study requirements and visits.
- Provided written informed consent.
- Recent onset macular involving rhegmatogenous retinal detachment.
- Retinal detachment due to single or multiple tears in the superior retina.
- Fellow eye visual acuity of 6/12 or better.
You will not qualify if you...
- History of medical, surgical, or other conditions limiting study participation (e.g., unstable diabetes, poorly controlled hypertension).
- Travel limitations preventing review at scheduled study intervals.
- Inability to provide informed consent.
- Anaesthetic risk factors or inability to lie supine for 1 hour.
- Pregnant and/or breastfeeding.
- Current systemic or ocular infection.
- Unable to return for post-treatment visits.
- Known inability to attend emergency department if adverse event occurs.
- Significant vitreous haemorrhage obscuring retina examination in study eye.
- Retinal tears below superior region not identified at screening or pre-op.
- Clinical signs of proliferative vitreoretinopathy.
- Myopia greater than -4 D spherical equivalent.
- History of glaucoma or elevated intraocular pressure over 21 mmHg.
- Prior or current intraocular infection.
- Fellow eye visual acuity worse than 6/12.
- Fellow eye myopia greater than -4 D or axial length over 26 mm if known.
- Any sight-threatening pathology in fellow eye.
- Extensive lattice degeneration.
- Unilateral high myopia.
- Family history of retinal detachment.
- Collagen disorders like Marfan's or Sticklers syndrome.
- History of ocular trauma.
- Any abnormality of eye structure as determined by investigator.
- Planned surgery during the study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Royal Victorian Eye and Ear Hospital (RVEEH)
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
P
Peter Keller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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