Rhegmatogenous Retinal Detachment - Macula OffNCT06468397
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
A study testing iSeelr™ in people with Rhegmatogenous Retinal Detachment - Macula Off, run by Photofuse Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment - Macula Off
- What is being tested?
- iSeelr™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Sep 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- Current ocular infection
- Unable to return for post-treatment visits
- Known inability to attend the emergency department in the event of an adverse event.
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Royal Victorian Eye and Ear Hospital (RVEEH)
East Melbourne, Victoria, 3002
Peter Keller, +61 3 9929 8348, peter.keller@eyeandear.org.au
Penelope Allen, FRANZO
About this study
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
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.
Read the 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).
- Being tested
- iSeelr™
- Keywords
- retinal detachment repair, laser, air, photocoagulation, photodehydration, gas tamponade, rhegmatogenous retinal detachment, 1940nm, retinal thermofusion, medical device, iSeelr™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSeelr™Device
The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear
| Study group | Role | What they receive |
|---|---|---|
| Retinal Thermofusion | Experimental | Surgical treatment using the iSeelr™ medical device for retinal detachment repair Receives: Device: iSeelr™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments.
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
Measured: Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment
Assessment of intra-operative and post-operative adverse events
To assess the safety of the treatment and the significance of any adverse events
Measured: Up to 90 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start13 Sep 2024
- Primary completion1 Mar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal Detachment - Macula OffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First in human use of investigational device called iSeelr™ system for the treatment of Rhegmatogenous Retinal Detachment
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Photofuse Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Penelope Allen, FRANZO, Principal investigator, The Royal Victorian Eye and Ear Hospital (RVEEH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468397
- Sponsor's protocol ID
- RTF-CIP-01
- Other IDs
- CDMRP-W81XWH-21-1-0730
- Status last verified
- Aug 2025
- First submitted
- 27 May 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed as a complete dataset in the Clinical Study Report
Publications
Heriot WJ, Metha AB, He Z, Lim JKH, Hoang A, Nishimura T, Okada M, Bui BV. Optimizing Retinal Thermofusion in Retinal Detachment Repair: Achieving Instant Adhesion without Air Tamponade. Ophthalmol Sci. 2022 Jun 13;2(4):100179. doi: 10.1016/j.xops.2022.100179. eCollection 2022 Dec.
PubMed 36531586
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06468397
- Acronym / sponsor ID
- RTF-CIP-01
- Keywords
- retinal detachment repair, laser, air, photocoagulation, photodehydration, gas tamponade, rhegmatogenous retinal detachment, 1940nm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Photofuse Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First in human use of investigational device called iSeelr™ system for the treatment of Rhegmatogenous Retinal Detachment
| Arm | Type | Receives |
|---|---|---|
| Retinal Thermofusion | Experimental | Device: iSeelr™Surgical treatment using the iSeelr™ medical device for retinal detachment repair |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 50 years or older.
- Willing and able to comply with all study requirements and visits.
- Provided written informed consent.
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSeelr™The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear | Device | Retinal Thermofusion |
Primary outcome
To assess the safety and performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments.
Time frame: 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
Time frame: Up to 90 days post treatment
To assess the safety of the treatment and the significance of any adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 36531586Heriot WJ, Metha AB, He Z, Lim JKH, Hoang A, Nishimura T, Okada M, Bui BV. Optimizing Retinal Thermofusion in Retinal Detachment Repair: Achieving Instant Adhesion without Air Tamponade. Ophthalmol Sci. 2022 Jun 13;2(4):100179. doi: 10.1016/j.xops.2022.100179. eCollection 2022 Dec.
- Individual participant dataSharing planned: No. Data will be analyzed as a complete dataset in the Clinical Study Report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Penelope Allen, FRANZO principal investigator
The Royal Victorian Eye and Ear Hospital (RVEEH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSeelr™ in people with Rhegmatogenous Retinal Detachment - Macula Off, run by Photofuse Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Keller (+61 3 9929 8348, peter.keller@eyeandear.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and performance of the investigational device, iSeelr™ System for the treatment of rhegmatogenous retinal detachments. (time frame: Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06468397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.