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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06833060




Registration number
NCT06833060
Ethics application status
Date submitted
12/02/2025
Date registered
18/02/2025

Titles & IDs
Public title
Transscleral Selective Laser Trabeculoplasty Project
Scientific 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
Secondary ID [1] 0 0
TSLT-001-2023
Universal Trial Number (UTN)
Trial acronym
TSLT project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma,Open-Angle 0 0
Ocular Hypertension (OH) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Selective Laser Trabeculoplasty

Experimental: Transscleral Selective Laser trabeculoplasty treatment - The Glaucoma or Ocular Hypertension participants will be treated using Transscleral Selective Trabeculoplasty laser device.


Treatment: Devices: Selective Laser Trabeculoplasty
Treatment of Glaucoma or Ocular Hypertension participants using Transscleral Selective Laser Trabeculoplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Treatment-Related Adverse Events
Timepoint [1] 0 0
From treatment to 30 days after
Primary outcome [2] 0 0
Intensity of Treatment-Related Adverse Events
Timepoint [2] 0 0
From treatment to 30 days after
Secondary outcome [1] 0 0
Ability of the TSLT device to decrease the patient's Intraocular pressure
Timepoint [1] 0 0
30 days after treatment
Secondary outcome [2] 0 0
Benchmark with the available Direct Selective Laser Trabecuplasty studies data
Timepoint [2] 0 0
30 days after treatment
Secondary outcome [3] 0 0
Trabecular meshwork targeting
Timepoint [3] 0 0
Day of treatment
Secondary outcome [4] 0 0
Usability assessment
Timepoint [4] 0 0
Day of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Central Adelaide Local Health Network - Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quantel Medical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert J. CASSON, MBBS (Hons), M.Biostat, DPhil
Address 0 0
Royal Adelaide Hospital - Harley Eye Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
HILAIRE
Address 0 0
Country 0 0
Phone 0 0
473745745
Fax 0 0
Email 0 0
rhilaire@quantelmedical.fr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06833060