Transscleral Selective Laser Trabeculoplasty Project

NCT06833060 | Recruiting

• 1 other identifier: TSLT-001-2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma,Open-Angle; Ocular Hypertension (OH)

Outcome Measures

Primary Outcomes (2)

• Frequency of Treatment-Related Adverse Events

  From treatment to 30 days after

• Intensity of Treatment-Related Adverse Events

  From treatment to 30 days after

Secondary Outcomes (4)

• Ability of the TSLT device to decrease the patient's Intraocular pressure

  30 days after treatment

• Benchmark with the available Direct Selective Laser Trabecuplasty studies data

  30 days after treatment

• Trabecular meshwork targeting

  Day of treatment

• Usability assessment

  Day of treatment

Study Arms (1)

Transscleral Selective Laser trabeculoplasty treatment

EXPERIMENTAL

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

Device: Selective Laser Trabeculoplasty

Interventions

Selective Laser Trabeculoplasty DEVICE

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

Also known as: Transscleral Selective Laser Trabeculoplasty

Transscleral Selective Laser trabeculoplasty treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumibird Medical (Quantel Medical, Ellex Medical, Optotek): lead
• Quantel Medical: collaborator

Study Sites (1)

Central Adelaide Local Health Network - Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Robert J. CASSON, MBBS (Hons), M.Biostat, DPhil

  Royal Adelaide Hospital - Harley Eye Clinic

  PRINCIPAL INVESTIGATOR

• Mario de La TORRE, Prof. Dr. med.

  Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

  STUDY DIRECTOR

Central Study Contacts

HILAIRE

CONTACT

473745745; rhilaire@quantelmedical.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: June 19, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)