Acute Retinal Detachment Repair With the iSeelr™ Retinal Detachment Repair System

NCT06468397 | Recruiting DMC

• 2 other identifiers: RTF-CIP-01CDMRP-W81XWH-21-1-0730
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhegmatogenous Retinal Detachment - Macula Off

Keywords

retinal detachment repair; laser; air; photocoagulation; photodehydration; gas tamponade; rhegmatogenous retinal detachment; 1940nm; retinal thermofusion; medical device; iSeelr™

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 90 days post treatment

Study Arms (1)

Retinal Thermofusion

EXPERIMENTAL

Surgical treatment using the iSeelr™ medical device for retinal detachment repair

Device: iSeelr™

Interventions

iSeelr™ DEVICE

The iSeelr™ device will be used to deliver 1940nm laser output along with low airflow to seal a retinal tear

Retinal Thermofusion

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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:
• Visual acuity of 6/12 or better.

You may not qualify if:

• 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.
• Significant vitreous haemorrhage partially or fully obscuring detailed examination of the retina
• 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

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• Photofuse Pty Ltd: lead

Study Sites (1)

The Royal Victorian Eye and Ear Hospital (RVEEH)

East Melbourne, Victoria, 3002, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 36531586 BACKGROUND

Study Officials

• Penelope Allen, FRANZO

  The Royal Victorian Eye and Ear Hospital (RVEEH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Keller

CONTACT

+61 3 9929 8348; peter.keller@eyeandear.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First in human use of investigational device called iSeelr™ system for the treatment of Rhegmatogenous Retinal Detachment

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 21, 2024
• Study Start: September 13, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)