RecruitingNot ApplicableNCT06833060

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

Sponsor

Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

Enrollment

15 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Glaucoma, Open-Angle Ocular Hypertension (OH)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new way to perform selective laser trabeculoplasty (SLT) — a laser procedure used to lower eye pressure in glaucoma — by delivering the laser through the white of the eye (transscleral approach) rather than through the pupil. The goal is to see whether this approach is as effective and safe as the standard method. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with open-angle glaucoma or high eye pressure (ocular hypertension) that warrants treatment - Your glaucoma is mild to moderate in severity - Your eye pressure is between 22 and 35 mmHg after stopping any pressure-lowering drops - You can attend all required study visits over 60 days **You may NOT be eligible if...** - You have severe glaucoma or a narrow-angle type of glaucoma - The structures of your eye do not allow the procedure to be safely performed - You cannot commit to the follow-up schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.