Ireland
--:--IST
Recruiting Not applicable

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

NCT06468397 · tracked via the Priya Life Science Australia tracker
Sponsor
Photofuse Pty Ltd
Phase
Not applicable
Started
2024-09-13
Last updated
2026-01-14

Condition(s) studied

Rhegmatogenous Retinal Detachment - Macula Off

Investigational drug(s) / intervention(s)

iSeelr™

iSeelr™: The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
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. 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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
The Royal Victorian Eye and Ear Hospital (RVEEH) East Melbourne Victoria Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06468397 on ClinicalTrials.gov ↗ ← All trials in Australia