Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Location status: Recruiting
NCT Number: NCT06833060
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Adelaide, South Australia, 5000, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty
Other names: Transscleral Selective Laser Trabeculoplasty
Time frame: From treatment to 30 days after
Time frame: From treatment to 30 days after
Time frame: 30 days after treatment
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
Time frame: Day of treatment
Demonstration of the right targeting of the trabecular meshwork by the device using OCT images.
Time frame: Day of treatment
Evaluation of how easily users can interact with the device and how this device can improve the treatment delivery (questionnaire)
Contact information is provided by the study sponsor or research team.
Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
Industry
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
Acronym: TSLT project
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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