Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT06833060
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06833060
Study Brief:
Protocol Section:
NCT06833060