Hypertension Trial, Recruiting

Written by an AI model from the 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 between 22 and 85 years old
• People who have been diagnosed with glaucoma that has not been controlled by the maximum amount of eye drop or medication treatment that can be tolerated
• People whose glaucoma did not improve after one or more eye operations (such as filtering surgery or a tube implant) or after procedures that reduce fluid production in the eye
• People whose eye condition (such as scarring on the eye surface or internal eye inflammation) means that standard glaucoma surgery would be less likely to work well
• People diagnosed specifically with open-angle glaucoma or glaucoma caused by an eye injury
• People whose eye pressure, while on stable maximum tolerated medication for at least 30 days, is between 25 and 45 mmHg
• People who still have at least some vision — even just the ability to detect light — in the eye being studied
• People who show signs of glaucoma damage to the optic nerve or surrounding nerve fibre layer, visible on examination
• People whose vision field test results show damage consistent with glaucoma, including specific patterns of reduced vision in the tested eye
• People who have at least two clock-hour sections of undisturbed eye surface tissue (conjunctiva) near the edge of the cornea, located between the 10 o'clock and 2 o'clock positions, in the eye being studied
• People whose eye anatomy in the front chamber is assessed as suitable for the procedure (confirm with trial site)
• People who are willing and able to follow all study procedures and aftercare instructions, and who are able to provide informed consent

Who may not be able to join:

• People with active abnormal blood vessel growth on the iris, cornea, or retina in the study eye
• People with pigmentary glaucoma in the study eye
• People with angle-closure glaucoma in the study eye
• People with a condition called pseudoexfoliation syndrome in the study eye
• People with iridocorneal endothelial syndrome in the study eye
• People with glaucoma caused by eye inflammation (uveitic glaucoma) in the study eye
• People with certain types of tissue abnormality inside the eye (epithelial or fibrous downgrowth) in the study eye
• People with corneal conditions that would interfere with normal healing after surgery or make it hard to see the implant clearly inside the eye (for example, Fuchs' dystrophy)
• People who have had any eye surgery in the study eye within the six months before the pre-study visit
• People whose cornea has a low cell count (fewer than 1,600 cells per square millimetre) in the study eye
• People who are expected to need further eye surgery or retinal laser treatment in the study eye within 12 months of joining
• People who need glaucoma surgery combined with another eye procedure (such as cataract removal) at the same time
• People who are unwilling to stop wearing contact lenses in the study eye after surgery
• People whose central corneal thickness falls outside the range of 490 to 620 micrometres in the study eye
• People who have had a significant eye infection or inflammation in the study eye within 60 days before the pre-study visit, or who have any active whole-body infection
• People with any condition that would prevent the device from being placed in the upper part of the study eye
• People who have gel-like fluid (vitreous) in the front part of the study eye that would require surgical removal
• People with a cataract in the study eye that significantly affects their vision
• People with poorly controlled diabetes (as indicated by a blood sugar measurement called HbA1c above 8% within three months of the procedure)
• People currently receiving treatment for cancer
• People taking medications or having other health conditions that could interfere with wound healing (such as immunosuppressive drugs)
• People currently participating in another clinical trial
• People who regularly take part in activities involving submerging their head underwater, such as diving or swimming
• People who are pregnant, breastfeeding, planning a pregnancy, or of childbearing potential without a reliable method of contraception
• People with a life expectancy of less than one year

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