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NCT06833060Completed

Transscleral Selective Laser Trabeculoplasty Project

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

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
15 (actual)
First submitted
12 Feb 2025
Start date
19 Jun 2025
Primary completion date
30 Jul 2026
Lead sponsor
Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
NCT number
NCT06833060

What you commit to

  • Study type: Interventional
  • Participants enrolled: 15
  • From 19 Jun 2025 to the primary completion date, 30 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • More than two hypotensive medications required (combination drops are considered 2 medications)
  • Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
  • Prior corneal refractive surgery
  • Complicated cataract surgery ≤ 6 months prior to enrollment
  • In the opinion of the investigator the participant might require other ocular surgery within the 12-months, unless for further reduction of their IOP.
  • Concurrent treatment with topical, nasal, inhaled or systemic steroids.

Other illness

  • Clinically significant disease in either eye as determined by the Investigator
  • Dense pigmentation or hemorrhage in the peri-limbal conjunctiva or anterior sclera, Pigmented Pinguecula and Pterigium
  • Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
  • Protected or vulnerable subjects (including but not limited to people with impaired intellectual functioning or mental illness, prisoners, terminally ill subjects, immunocompromised…)

Other

  • 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 points (i.e., 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
    • Points within the central 5 degrees of fixation with a sensitivity \<15 dB in both hemifields on the decibel plot
    • A visual field MD of worse than -12dB in the fellow eye
  • Cup: Disc Ratio more than 0.8
  • Presence of visually significant cataract in the opinion of the investigator
  • Clinically significant amblyopia in either eye
  • Women who are pregnant or may become pregnant during the course of the study
  • Participation in another clinical study
  • People not able to read and understand the informed consent
  • People not able to read and understand English language

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Central Adelaide Local Health Network - Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.