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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06468397




Registration number
NCT06468397
Ethics application status
Date submitted
27/05/2024
Date registered
21/06/2024
Date last updated
24/06/2024

Titles & IDs
Public title
Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System
Scientific 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
Secondary ID [1] 0 0
RTF-CIP-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhegmatogenous Retinal Detachment - Macula Off 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iSeelr™

Experimental: Retinal Thermofusion - Surgical treatment using the iSeelr™ medical device for retinal detachment repair


Treatment: Devices: iSeelr™
The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with successful retinal reattachment without the need for gas tamponade
Timepoint [1] 0 0
Assessment will take place before discharge on day of surgery and on days 1 and 2 post treatment
Primary outcome [2] 0 0
Assessment of intra-operative and post-operative adverse events
Timepoint [2] 0 0
Up to 90 days post treatment

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Victorian Eye and Ear Hospital (RVEEH) - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Photofuse Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Penelope Allen, FRANZO
Address 0 0
The Royal Victorian Eye and Ear Hospital (RVEEH)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter Keller
Address 0 0
Country 0 0
Phone 0 0
+61 3 9929 8348
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06468397