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
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.
• Age 18 years or older with OAG or OHT who are clinical candidates for routine SLT.
• Mild to moderate OAG (defined as a mean deviation on the Humhprey Field Analyzer \[HFA\] \> -12.0 dB), resulting from primary open-angle glaucoma (POAG), or pseudoexfoliative glaucoma
• OHT with open angles warranting IOP-lowering treatment
• IOP ≥ 22mmHg or ≤ 35mmHg (after washout of any IOP-lowering medications)
• Gonioscopically visible scleral spur for 360 degrees without indentation
• Ability to visualize the peri-limbal sclera for 360 degrees (using a manual elevation of the lid)
• Willing and able to participate in the 60 days +/-5 days study, to comply with the study procedures and to adhere to the follow-up schedule.
• Participant capable of giving informed consent