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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty
Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGFrequency of Treatment-Related Adverse Events
Time frame: From treatment to 30 days after
Intensity of Treatment-Related Adverse Events
Time frame: From treatment to 30 days after
Ability of the TSLT device to decrease the patient's Intraocular pressure
IOP reduction after TSLT treatment will be compared to the 20% threshold efficacy point as defined in the SLT literature
Time frame: 30 days after treatment
Benchmark with the available Direct Selective Laser Trabecuplasty studies data
Time frame: 30 days after treatment
Trabecular meshwork targeting
Demonstration of the right targeting of the trabecular meshwork by the device using OCT images.
Time frame: Day of treatment
Usability assessment
Evaluation of how easily users can interact with the device and how this device can improve the treatment delivery (questionnaire)
Time frame: Day of treatment
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