Can a laser treat glaucoma without touching the eye?
NCT ID NCT06833060
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This pilot study tests a new laser device for treating open-angle glaucoma and ocular hypertension. The device uses a laser through the sclera (the white of the eye) to lower eye pressure, avoiding the need for a lens to touch the cornea. Researchers will check how safe the procedure is and whether it reduces eye pressure by at least 20% in the 30 days after treatment. The study involves 15 adults who are candidates for standard laser trabeculoplasty.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transscleral Selective Laser Trabeculoplasty (TSLT) using a laser-OCT integrated system with eye tracking
- What this could lead to
- If successful, this could offer a safer, faster, and more comfortable laser treatment for glaucoma, reducing eye pressure without corneal contact.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The procedure could still cause side effects or fail to lower eye pressure enough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Adelaide Local Health Network - Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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Other studies related to the condition(s) this trial covers.
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