Transscleral selective laser trabeculoplasty for open-angle glaucoma and ocular hypertension

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

This study will try the ELLEX transscleral selective laser trabeculoplasty (TSLT) to see if it safely lowers eye pressure in adults with open-angle glaucoma or ocular hypertension.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) (Industry-sponsored)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06833060 on ClinicalTrials.gov

What this trial studies

Adults with mild-to-moderate primary open-angle glaucoma or ocular hypertension will receive a single transscleral selective laser trabeculoplasty (TSLT) treatment using the ELLEX device at a single center. The procedure delivers low-energy laser pulses through the sclera without a corneal contact lens, aiming to lower intraocular pressure (IOP) while reducing corneal contact–related risks. Participants will attend four visits: screening, treatment, and follow-up at 1 day and 30 days post-treatment, with IOP measurements and safety checks recorded. The study will record IOP change and any adverse events to characterize the safety and effectiveness of this non-contact approach.

Who should consider this trial

Good fit: Adults (≥18 years) with mild-to-moderate primary open-angle glaucoma or ocular hypertension who are clinical candidates for SLT, have gonioscopically visible scleral spur for 360 degrees, and an IOP of 22–35 mmHg after medication washout are ideal candidates.

Not a fit: Patients with angle-closure, congenital or developmental glaucoma, pigmentary or other secondary glaucomas, corneal abnormalities that contraindicate SLT, or inability to visualize the peri-limbal sclera are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this device could provide a simpler, quicker, non-contact laser option to lower eye pressure with fewer corneal-related complications.

How similar studies have performed: Conventional contact-lens SLT is well established to lower IOP, but transscleral non-contact SLT is a newer approach with limited published outcome data to date.

Eligibility criteria

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:

* 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

Where this trial is running

Adelaide, South Australia

• Central Adelaide Local Health Network - Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Principal investigator: Robert J. CASSON, MBBS (Hons), M.Biostat, DPhil — Royal Adelaide Hospital - Harley Eye Clinic
• Study coordinator: Hilaire

Conditions Glaucoma,Open-Angle; Ocular Hypertension