NCT06833060

Transscleral Selective Laser Trabeculoplasty Project

Exploratory Clinical Study of a Laser-OCT Integrated System With Eye Tracking to Treat Glaucoma and OHT With Transscleral Selective Laser Trabeculoplasty Technology A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to determine how safe and effective (how well it works) the ELLEX TSLT device is for the treatment of Glaucoma and Ocular Hypertension using Transscleral Selective Laser Trabeculoplasty. Selective Laser Trabeculoplasty (SLT) is a type of laser therapy that uses short pulses of low-energy light to lower eye pressure. This treatment uses a lens in contact with the front part of the eye (called cornea) which may lead to complications. Transscleral Selective Laser Trabeculoplasty allows the doctor to perform the laser treatment without the lens coming into contact with the cornea, potentially offering a simpler, quicker and safer approach for both participants and doctors. Participants will be required to attend four study visits. The first visit will assess the disease, the second will involve the TSLT laser treatment for the participant's condition (glaucoma or ocular hypertension), and the final two visits, at 1 day and 30 days post-treatment, will evaluate the treatment's efficacy and the procedure's safety.

Conditions

• Glaucoma,Open-Angle
• Ocular Hypertension (OH)

Interventions

Type	Name	Description
DEVICE	Selective Laser Trabeculoplasty	Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty

Timeline

• Start date: 2025-06-19
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-02-18
• Last updated: 2025-06-26

Locations

1 site across 1 country: Australia