Glaucoma,Open-AngleTSLT projectNCT06833060
Transscleral Selective Laser Trabeculoplasty Project
A study testing Selective Laser Trabeculoplasty in people with Glaucoma,Open-Angle and Ocular Hypertension (OH), run by Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma,Open-Angle, Ocular Hypertension (OH)
- What is being tested?
- Selective Laser Trabeculoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Jun 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
Official title: 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
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.
- Conditions
- Glaucoma,Open-Angle, Ocular Hypertension (OH)
- Being tested
- Selective Laser Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser TrabeculoplastyDevice
Also called Transscleral Selective Laser Trabeculoplasty
Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty
| Study group | Role | What they receive |
|---|---|---|
| Transscleral Selective Laser trabeculoplasty treatment | Experimental | The Glaucoma or Ocular Hypertension participants will be treated using Transscleral Selective Trabeculoplasty laser device. Receives: Device: Selective Laser Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment-Related Adverse Events
Measured: From treatment to 30 days after
Intensity of Treatment-Related Adverse Events
Measured: From treatment to 30 days after
Secondary outcomes (4)
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
Measured: 30 days after treatment
Benchmark with the available Direct Selective Laser Trabecuplasty studies data
Measured: 30 days after treatment
Trabecular meshwork targeting
Demonstration of the right targeting of the trabecular meshwork by the device using OCT images.
Measured: 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)
Measured: Day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start19 Jun 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma,Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quantel Medical
- Responsible party
- Sponsor
- Investigators
- Robert J. CASSON, MBBS (Hons), M.Biostat, DPhil, Principal investigator, Royal Adelaide Hospital - Harley Eye ClinicMario de La TORRE, Prof. Dr. med., Study director, Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833060
- Sponsor's protocol ID
- TSLT-001-2023
- Acronym
- TSLT project
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06833060
- Acronym / sponsor ID
- TSLT project / TSLT-001-2023
- Conditions
- Glaucoma,Open-Angle, Ocular Hypertension (OH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)Industry (pharma, biotech, devices)
- Collaborators
- Quantel Medical
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transscleral Selective Laser trabeculoplasty treatment | Experimental | Device: Selective Laser TrabeculoplastyThe Glaucoma or Ocular Hypertension participants will be treated using Transscleral Selective Trabeculoplasty laser device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (29 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Laser TrabeculoplastyAlso: Transscleral Selective Laser TrabeculoplastyTreatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty | Device | Transscleral Selective Laser trabeculoplasty treatment |
Primary outcome
Frequency 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
4 secondary outcomes
Ability of the TSLT device to decrease the patient's Intraocular pressure
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
Time frame: Day of treatment
Usability assessment
Time frame: Day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Laser Trabeculoplasty in people with Glaucoma,Open-Angle and Ocular Hypertension (OH), run by Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Treatment-Related Adverse Events (time frame: From treatment to 30 days after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.