Macular Degeneration 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 who are 55 years of age or older.
• People who have been diagnosed with late-stage age-related macular degeneration (AMD), specifically with damage to the central part of the retina in both eyes.
• People who have had cataract surgery with lens implants placed in both eyes, at least 6 months before joining the trial.
• People whose best corrected vision (with glasses or contact lenses) falls within a specific range — not better than 20/80 and not worse than 20/800 — in both eyes.
• People who have enough side (peripheral) vision in the eye not scheduled for surgery to move around safely.
• People whose vision in the eye scheduled for surgery improves by at least 2 lines on a standard eye chart when tested with a special telescopic device used in this trial.
• People with a certain minimum depth measurement inside the front part of the eye (at least 2.5 mm) in both eyes (confirm with trial site).
• People with a healthy enough cell count on the inner surface of the cornea (at least 1,600 cells per square millimetre) in both eyes.
• People who are willing to take part in a training program after surgery to learn how to use the implant being studied.
• People who have read and signed an informed consent form approved by the ethics committee before any trial procedures begin.
• People who are registered with a national social security system or equivalent in the country where they sign consent.
• Women who are not pregnant and not breastfeeding, and who are either not of childbearing potential, or who agree to follow the trial's contraception guidance from the screening visit through to the end of the study.

Who may not be able to join:

• People who have signs of active abnormal blood vessel growth under the retina (choroidal neovascularisation), or who have been treated for this condition in both eyes within the past 6 months.
• People who have diabetic retinopathy in both eyes.
• People who have diseases affecting the blood vessels of the retina in both eyes.
• People with a history of a detached retina in both eyes.
• People who have retinitis pigmentosa in both eyes.
• People who have a tumour inside the eye in both eyes.
• People who have certain corneal conditions affecting the layers of the cornea in both eyes, such as corneal guttata.
• People who are prone to rubbing their eyes in both eyes.
• People whose eye has a very narrow drainage angle (a specific internal eye structure measurement) in the eye scheduled for surgery (confirm with trial site).
• People whose eye length falls outside a specific range (less than 21 mm or more than 26 mm) in the eye scheduled for surgery.
• People who have a current or past history of inflammation, infection, or swelling inside the eye — such as uveitis, iritis, or keratitis — in the eye scheduled for surgery.
• People who have a specific type of lens implant (plate haptic style) already in the eye scheduled for surgery.
• People who have had the gel inside the eye (vitreous) surgically removed in the eye scheduled for surgery.
• People with weakness or instability of the structures that hold the lens in place, or a condition called pseudoexfoliation, in the eye scheduled for surgery.
• People with certain iris (coloured part of the eye) abnormalities — such as pigment dispersion syndrome, aniridia, or abnormal blood vessel growth on the iris — in the eye scheduled for surgery.
• People who already have a lens implant placed in the sulcus (a specific position inside the eye) in the eye scheduled for surgery.
• People who have a toric or multifocal lens implant in the eye scheduled for surgery.
• People who have a disease of the optic nerve in the eye scheduled for surgery.
• People with a history of eye pressure that rose uncontrollably due to steroid use, glaucoma, or a current eye pressure above 22 mmHg.
• People with a known sensitivity or allergy to medications typically used after eye surgery.
• People with significant difficulties communicating or severe neurological conditions.
• People who have taken part in another clinical trial within 30 days before joining, or who plan to join another clinical trial at the same time.
• People who, in the opinion of the investigating doctor, have any condition or situation that could put them at significant risk, affect the trial results, or interfere with their ability to participate fully.
• People who are unable to understand and give informed consent due to being under legal guardianship or incarceration.

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