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

NCT06468397 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-14

No results posted yet for this study

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

Interventions

DEVICE

iSeelr™

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

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Photofuse Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Penelope Allen, FRANZO · The Royal Victorian Eye and Ear Hospital (RVEEH)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2026-03-01
Completion
2026-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468397 on ClinicalTrials.gov