Recruiting
Not applicable
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
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
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)
| Facility | City | Region | Status |
| The Royal Victorian Eye and Ear Hospital (RVEEH) |
East Melbourne |
Victoria |
Recruiting |