Glaucoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 20 or older, of any sex
• People who have been diagnosed with open angle glaucoma in the eye being studied
• People whose eye's drainage angle (the angle between the iris and cornea) is classified as "open" or "wide open" according to a standard grading scale used by eye doctors — for people also having cataract surgery as part of the trial, a slightly narrower angle may be acceptable before surgery, as long as it meets the required grade before the device is placed (confirm with trial site)
• People whose glaucoma is not adequately managed with at least one eye drop medication to lower eye pressure — or people who cannot use such medications due to allergy, intolerance, or difficulty consistently accessing them
• People whose vision in the study eye is at least 20/200, and at least 20/100 in the other eye, as measured by a standard eye chart
• People whose optic nerve damage (measured by a cup-to-disc ratio) does not exceed 0.9 in the study eye
• People who are willing and able to follow the study's instructions and attend all scheduled appointments
• People who are able to provide written consent before any study procedures begin
• (Part 2 of the trial only) People who have an age-related cataract in the study eye that is suitable for a standard type of cataract removal surgery with lens implantation
• (Part 2 of the trial only) People whose cataract surgery goes smoothly and meets specific surgical conditions before the investigational device is placed, including that the lens capsule is intact and centred, the new lens is well-positioned, there are no signs of damage to the supporting structures of the lens, and the drainage angle of the eye could be clearly seen during surgery

Who may not be able to join:

• People whose eye drainage angle is classified as narrow, extremely narrow, or closed — except in the specific situation described for Part 2 cataract surgery participants (confirm with trial site)
• People who have had eye surgery on the study eye within the 90 days before the screening visit
• People who have been diagnosed with diabetes with a blood sugar control reading (HbA1c) above 7%
• People with a known or suspected allergy or sensitivity to medical-grade silicone
• People with an allergy to fluorescein (a dye used in eye examinations)
• People whose cornea is cloudy or whose eye's drainage angle cannot be clearly viewed through the examination lens, making correct placement of the device impossible
• People whose corneal cell count (a measure of the health of the front surface of the eye) falls below a certain threshold at screening — specifically, fewer than 1,900 cells per square millimetre, or a certain level of irregular cell variation — though a small allowance of up to 5% below this count may be considered if the investigator judges it appropriate (confirm with trial site)
• People who are expected to need additional eye surgery or a retinal laser procedure during the study period
• People whose eye anatomy puts them at high risk of developing a type of glaucoma caused by a closed drainage angle
• People with existing eye or general health conditions that, in the investigator's opinion, are likely to cause complications after the implant procedure
• People whose central corneal thickness measures greater than 600 microns
• People with significant degenerative eye conditions that, in the investigator's opinion, could affect study assessments — for example, certain retinal disorders
• People with significant corneal disease in the study eye, such as certain inherited corneal conditions
• People whose natural lens in the study eye has shifted out of its normal position
• People who are unable to complete standard visual field testing in either eye
• People who have vitreous material (the gel from inside the eye) present in the front chamber of the study eye
• People with significant inflammation or infection inside the eye
• People who have silicone oil present in the study eye
• People who have taken part in another drug or device study in the past 3 months, or who plan to join another study during this trial
• Women who could become pregnant and test positive on a pregnancy test at the screening visit, or who are currently pregnant or breastfeeding
• People who are under legal guardianship or trusteeship
• People whose ability to give personal informed consent is compromised for any reason
• (Part 2 only) People whose cataract in the study eye was not caused by ageing — for example, cataracts resulting from an injury, inflammation, or diabetes
• People who are unable to stop taking blood thinning or antiplatelet medications for the surgical procedure (the timing and management of any pause in such medications would be determined by the principal investigator, in consultation with the person's usual care team)

Important: Always verify eligibility with the trial site directly before applying.