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New treatment option for Rhegmatogenous Retinal Detachment - Macula Off
Official title Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
ClinicalTrials.gov ID: NCT06468397
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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:
You likely can't join if
- History of medical, surgical, or other conditions that, in the opinion of the investigator, would limit study participation e.g. unstable diabetes...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- East Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.