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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Contraindications to conventional SLT (e.g. corneal abnormalities etc.)
* Angle Closure Glaucoma
* Congenital or developmental glaucoma
* Secondary glaucoma included pigmentary glaucoma
* Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
* Presence of any peripheral anterior synechiae (PAS) in the study eye
* Any of the following visual field findings using the Humphrey visual field analyzer:
* A HFA MD of worse than -12dB
* Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
* At least 50% of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Treatment-Related Adverse Events
Timeframe: From treatment to 30 days after
2
Intensity of Treatment-Related Adverse Events
Timeframe: From treatment to 30 days after
Trial details
NCT IDNCT06833060
SponsorLumibird Medical (Quantel Medical, Ellex Medical, Optotek)