Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System (NCT06468397) | Clinical Trial Compass
RecruitingNot Applicable
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
Australia10 participantsStarted 2024-09-13
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety and performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments.
Timeframe: Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment
2
Assessment of intra-operative and post-operative adverse events