Transscleral Selective Laser Trabeculoplasty Project (TSLT project)

Lumibird Medical (Quantel Medical, Ellex Medical, Optotek)

Status

Not yet enrolling

Conditions

Glaucoma,Open-Angle

Ocular Hypertension (OH)

Treatments

Device: Selective Laser Trabeculoplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT06833060

TSLT-001-2023

Details and patient eligibility

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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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