Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
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
Photofuse Pty Ltd
10 participants
Sep 13, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria25
- 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 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
- 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
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Interventions
The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06468397