Laser breakthrough could speed up retinal detachment recovery
NCT ID NCT06468397
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new laser device called iSeelr™ that seals retinal tears during surgery without needing a gas bubble. The goal is to make recovery faster and safer for people with a detached retina. Ten adults aged 50 and older with a specific type of retinal detachment will be enrolled to check if the device works and is safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Royal Victorian Eye and Ear Hospital (RVEEH)
RECRUITINGEast Melbourne, Victoria, 3002, Australia