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CompletedNCT06833060TSLT projectUpdated Aug 10, 2026

Transscleral Selective Laser Trabeculoplasty Project

An interventional study of Selective Laser Trabeculoplasty in Glaucoma,Open-Angle and Ocular Hypertension (OH), sponsored by Lumibird Medical (Quantel Medical, Ellex Medical, Optotek). Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Glaucoma,Open-Angle
  • Ocular Hypertension (OH)
03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

This is the only study on the registry with Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 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
  • 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
  • Presence of visually significant cataract in the opinion of the investigator
  • Clinically significant disease in either eye as determined by the Investigator
  • Clinically significant amblyopia in either eye
  • Dense pigmentation or hemorrhage in the peri-limbal conjunctiva or anterior sclera, Pigmented Pinguecula and Pterigium
  • Women who are pregnant or may become pregnant during the course of the study
  • 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.
  • Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
  • Participation in another clinical study
  • Protected or vulnerable subjects (including but not limited to people with impaired intellectual functioning or mental illness, prisoners, terminally ill subjects, immunocompromised…)
  • People not able to read and understand the informed consent
  • People not able to read and understand English language
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Transscleral Selective Laser trabeculoplasty treatment

    The Glaucoma or Ocular Hypertension participants will be treated using Transscleral Selective Trabeculoplasty laser device.

    Device: Selective Laser Trabeculoplasty

Interventions

  • DeviceSelective Laser Trabeculoplasty

    Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty

    Also known as: Transscleral Selective Laser Trabeculoplasty

06

What researchers measure

Primary outcomes

  1. Frequency of Treatment-Related Adverse Events

    Time frame: From treatment to 30 days after

  2. Intensity of Treatment-Related Adverse Events

    Time frame: From treatment to 30 days after

Secondary outcomes

  1. 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

  2. Benchmark with the available Direct Selective Laser Trabecuplasty studies data

    Time frame: 30 days after treatment

  3. Trabecular meshwork targeting

    Demonstration of the right targeting of the trabecular meshwork by the device using OCT images.

    Time frame: Day of treatment

  4. 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

07

Study locations

1 site
  • Central Adelaide Local Health Network - Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06833060
Lead sponsor
Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
Collaborators
Quantel Medical
Responsible party
Sponsor
First posted
Feb 18, 2025
Start date
Jun 19, 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026
Last update
Aug 10, 2026

Study contacts

Robert J. CASSON, MBBS (Hons), M.Biostat, DPhil
principal investigator · Royal Adelaide Hospital - Harley Eye Clinic
Mario de La TORRE, Prof. Dr. med.
study director · Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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