Transscleral Selective Laser Trabeculoplasty Project

Korábbi kezelés

• 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
• 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.

Más betegség

• Clinically significant disease in either eye as determined by the Investigator
• Dense pigmentation or hemorrhage in the peri-limbal conjunctiva or anterior sclera, Pigmented Pinguecula and Pterigium
• Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
• Protected or vulnerable subjects (including but not limited to people with impaired intellectual functioning or mental illness, prisoners, terminally ill subjects, immunocompromised…)

Egyéb

• 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
• Presence of visually significant cataract in the opinion of the investigator
• Clinically significant amblyopia in either eye
• Women who are pregnant or may become pregnant during the course of the study
• Participation in another clinical study
• People not able to read and understand the informed consent
• People not able to read and understand English language

• 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