Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06833060

Transscleral Selective Laser Trabeculoplasty Project

Led by Lumibird Medical (Quantel Medical, Ellex Medical, Optotek) · Updated on 2025-06-26

15

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

Sponsors

L

Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

Lead Sponsor

Q

Quantel Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Transscleral Selective Laser Trabeculoplasty Project

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with open-angle glaucoma (OAG) or ocular hypertension (OHT) and clinical candidates for routine selective laser trabeculoplasty (SLT)
  • Mild to moderate OAG with mean deviation better than -12.0 dB on Humphrey Field Analyzer
  • OHT with open angles needing intraocular pressure (IOP) lowering treatment
  • IOP between 22 mmHg and 35 mmHg after stopping IOP-lowering medications
  • Visible scleral spur around 360 degrees by gonioscopy without indentation
  • Ability to see peri-limbal sclera for 360 degrees using manual lid elevation
  • Willing and able to participate in the study for about 60 days and follow study procedures
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to conventional SLT such as corneal abnormalities
  • Angle closure glaucoma
  • Congenital or developmental glaucoma
  • Secondary glaucoma including pigmentary glaucoma
  • Unable to perform reliable visual field test (fixation losses, false positives or negatives >33%)
  • Presence of peripheral anterior synechiae (PAS) in the study eye
  • Visual field defects worse than -12 dB on Humphrey visual field analyzer
  • Cup to disc ratio greater than 0.8
  • Use of more than two hypotensive medications (combination drops counted as two)
  • Prior incisional or laser glaucoma surgery, including previous SLT, in the study eye
  • Prior corneal refractive surgery
  • Complicated cataract surgery within 6 months before enrollment
  • Visually significant cataract as judged by investigator
  • Clinically significant disease or amblyopia in either eye
  • Dense pigmentation or hemorrhage in peri-limbal conjunctiva or anterior sclera; pigmented pinguecula and pterygium
  • Women who are pregnant or may become pregnant during the study
  • Likely need for ocular surgery within 12 months as judged by investigator unless for further IOP reduction
  • Current treatment with steroids (topical, nasal, inhaled, or systemic)
  • Uncontrolled systemic disease affecting ability to attend follow-up
  • Participation in another clinical study
  • Protected or vulnerable subjects including mental illness, prisoners, terminal illness, immunocompromised
  • Unable to read and understand informed consent or English language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Central Adelaide Local Health Network - Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Actively Recruiting

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Research Team

H

HILAIRE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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