Health TrialsbyHealthPanel

Transscleral Selective Laser Trabeculoplasty Project

ConditionsGlaucoma,Open-AngleOcular Hypertension (OH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumibird Medical (Quantel Medical, Ellex Medical, Optotek)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Contraindications to conventional SLT (e.g. corneal abnormalities etc.)

Angle Closure Glaucoma

Congenital or developmental glaucoma

Secondary glaucoma included pigmentary glaucoma

Trial design

Design model

Single group

Treatments tested in this trial

  • Selective Laser Trabeculoplasty

    Device

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Transscleral Selective Laser trabeculoplasty treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of Treatment-Related Adverse Events

Time frame
From treatment to 30 days after
2

Intensity of Treatment-Related Adverse Events

Time frame
From treatment to 30 days after

Secondary outcomes

1

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

Time frame
30 days after treatment
2

Benchmark with the available Direct Selective Laser Trabecuplasty studies data

Time frame
30 days after treatment
3

Trabecular meshwork targeting

Demonstration of the right targeting of the trabecular meshwork by the device using OCT images.

Time frame
Day of treatment
4

Usability assessment

Evaluation of how easily users can interact with the device and how this device can improve the treatment delivery (questionnaire)

Time frame
Day of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

Lead sponsor

Quantel Medical

Collaborator

Source ClinicalTrials.gov
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