About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Contraindications to conventional SLT (e.g. corneal abnormalities etc.)
Angle Closure Glaucoma
Congenital or developmental glaucoma
Secondary glaucoma included pigmentary glaucoma
Trial design
Treatments tested in this trial
- Selective Laser Trabeculoplasty
Treatment groups
Sponsors and collaborators
Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
Lead sponsor
Quantel Medical
Collaborator