iSeelr™ retinal thermofusion repair for recent macula-off retinal detachment
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
This will test the iSeelr™ laser retinal thermofusion technique to repair recent macula-off rhegmatogenous retinal detachments in people aged 50 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Photofuse Pty Ltd Industry-sponsored |
| Locations | 1 site (East Melbourne, Victoria) |
| Trial ID | NCT06468397 on ClinicalTrials.gov |
What this trial studies
This first-in-human trial uses the iSeelr™ device to perform retinal thermofusion, a two-step laser approach that dehydrates subretinal fluid around a retinal tear and then applies photocoagulation to seal the retina without using a gas bubble. Ten participants with recent macula-involving rhegmatogenous retinal detachment caused by superior tears will be treated and followed across seven visits over three months to monitor safety and device performance. The procedure aims to reduce recovery time and postoperative positioning compared with conventional gas tamponade techniques. The study is sponsored by Photofuse Pty Ltd, funded by the US Department of Defense, and conducted at the Royal Victorian Eye and Ear Hospital in Melbourne.
Who should consider this trial
Good fit: Ideal candidates are people aged 50 or older with a recent macula-involving rhegmatogenous retinal detachment from single or multiple superior retinal tears, who can provide informed consent, comply with follow-up visits, and have a fellow eye visual acuity of 6/12 or better.
Not a fit: Patients unlikely to benefit include those with longstanding or non-superior detachments, active ocular or systemic infections, significant uncontrolled medical conditions, pregnancy or breastfeeding, inability to lie supine for the procedure, or inability to attend required follow-up visits.
Why it matters
Potential benefit: If successful, the technique could seal retinal tears without a gas bubble, potentially shortening recovery time and reducing strict postoperative positioning.
How similar studies have performed: This is a first-in-human clinical trial; the retinal thermofusion method has been validated in laboratory and preclinical work but has not yet been shown safe or effective in people.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion criteria in the study eye: * Significant vitreous haemorrhage partially or fully obscuring detailed examination of the retina * Intraoperative identification of tears below the superior region in the area of retinal detachment not identified at the screening visit or during pre-operative examination. Note: Isolated retinal tears in attached retina, identified at any time are NOT an exclusion criterion and may be treated with lase as per standard of care * Clinical signs of PVR (+1 flare, vitreous clumps, pigment clusters on the inferior retina, rolled retinal tear edge, star-fold) * Myopia greater than -4 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 Exclusion criteria in the fellow eye: * Visual Acuity worse than 6/12 * Myopia greater than -4D 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
Where this trial is running
East Melbourne, Victoria
- The Royal Victorian Eye and Ear Hospital (RVEEH) — East Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Penelope Allen, FRANZO — The Royal Victorian Eye and Ear Hospital (RVEEH)
- Study coordinator: Peter Keller
- Email: peter.keller@eyeandear.org.au
- Phone: +61 3 9929 8348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.