Clinical trial NCT06468397: Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment - Macula Off
Keywords: retinal detachment repair
laser
air
photocoagulation
photodehydration
gas tamponade
rhegmatogenous retinal detachment
1940nm
retinal thermofusion
medical device
iSeelr™
Lead sponsor: Photofuse Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2024-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First in human use of investigational device called iSeelr™ system for the treatment of Rhegmatogenous Retinal Detachment
Primary purpose: TREATMENT

Brief 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.

Detailed description: The retina is a light-sensitive layer at the back of your eye that captures images. When light enters your eye, the retina turns it into signals that travel to your brain, helping you see. It's crucial for clear vision. When a retinal tear forms at the back of your eye, it can cause the fluid inside your eye to leak, leading to the retina peeling away and cause vision problems including blindness.

Retinal Thermofusion (RTF) uses a laser device called iSeelr™ to first dehydrate the fluid buildup around the retina and then laser treatment to seal the retina back in its place. The device was developed by Photofuse Pty Ltd and method validated in a laboratory with the Centre for Eye Research Australia and The University of Melbourne, Victoria, Australia.This clinical trial involves recruiting 10 participants with rhegmatogenous retinal detachment who will receive the treatment and be closely followed with 7 study visits over a three month period. This will allow us to assess the safety and performance of RTF. This research is being Sponsored by Photofuse Pty Ltd and is funded by the US Department of Defense (Award W81XWH-21-1-0730).

Eligibility 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 4 clock hours
* Pseudophakia

Fellow eye:

• Best Corrected Visual acuity (BCVA) 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

Exclusion criteria in the study eye:

* Significant vitreous haemorrhage partially or fully obscuring detailed examination of the retina
* Intraoperative identification of tears beyond the superior 4 clock hours not identified at the screening visit or during pre-operative examination
* Clinical signs of PVR (+1 flare, vitreous clumps, pigment clusters on the inferior retina, rolled retinal tear edge, star-fold)
* Phakic
* Myopia greater than 3 D spherical equivalent as confirmed by last refraction prior to becoming pseudophakic, and/or
* History of glaucoma or elevated intraocular pressure \>21
* Prior or current intraocular 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 fellow eye:

* Best corrected Visual Acuity (BCVA) worse than 6/12
* Axial length greater than 26mm
* 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 outcomes:
measure: Number of participants with successful retinal reattachment without the need for gas tamponade
timeFrame: Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment
measure: Assessment of intra-operative and post-operative adverse events
timeFrame: Up to 90 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: The Royal Victorian Eye and Ear Hospital (RVEEH)
state: Victoria
Study officials:
affiliation: The Royal Victorian Eye and Ear Hospital (RVEEH)
name: Penelope Allen, FRANZO
role: PRINCIPAL_INVESTIGATOR
References: