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 found to have a specific type of advanced age-related macular degeneration (a condition affecting the centre of the retina) confirmed by eye imaging tests.
• People who have a cataract (clouding of the eye's natural lens).
• People whose vision, even with the best glasses prescription, falls within a specific range — not better than 20/80 and not worse than 20/800 — in both eyes.
• People who have sufficient side (peripheral) vision in the eye not being operated on, as assessed by watching how they walk around.
• People whose vision in the eye planned for surgery improves by at least five letters on a standard eye chart when using a specific external telescope simulator provided by the trial.
• People whose eye planned for surgery has a front chamber depth (the space inside the front of the eye) of at least 2.5 mm.
• People who are willing to take part in a post-surgery training program to learn how to use the implant being studied.
• People who are able to read and understand the consent form and agree to take part before any study procedures begin.
• People who have a sufficient understanding of the local language to follow verbal and written instructions and are willing to meet all study requirements.

Who may not be able to join:

• People who have signs of active abnormal blood vessel growth under the retina, or who have been treated for this condition within the past six months.
• People who have any eye condition that affects peripheral (side) vision in the eye not being operated on.
• People who have a history of eye pressure that rose in response to steroid medications, uncontrolled glaucoma, or an eye pressure reading above 22 mm Hg before the procedure.
• People who have a specific corneal condition called corneal guttata (changes to cells on the inner surface of the cornea).
• People who have a known sensitivity or reaction to medications typically used after eye surgery.
• People who have significant difficulty communicating or who have a severe neurological (brain or nervous system) disorder.
• People who have previously had any surgery inside the eye or on the cornea of the eye planned for surgery, for any reason.
• People who have an eye condition that causes them to frequently rub their eyes.
• People who have had, or are expected to have, any eye-related surgery within 30 days before the implant surgery in this trial.
• People whose eye planned for surgery has certain measurements outside the acceptable range, including specific levels of short-sightedness or long-sightedness, eye length, inner corneal cell count, or a narrow drainage angle inside the eye (confirm with trial site).
• People who have an active inflammatory (swelling or infection-related) eye disease.
• People who have certain diseases affecting the layers of the cornea.
• People who have weakness or instability of the structures holding the eye's natural lens in place, or a condition called pseudoexfoliation.
• People who have diabetic retinopathy (eye damage caused by diabetes).
• People who have untreated tears in the retina.
• People who have disease affecting the blood vessels of the retina.
• People who have disease affecting the optic nerve.
• People who have a history of retinal detachment.
• People who have retinitis pigmentosa (an inherited condition that causes gradual vision loss).
• People who have a tumour inside the eye.
• People who have taken part in another clinical trial within 30 days before enrolling, or who plan to join another trial during this study.
• People who are employees (or close relatives of employees) of the organisations running or sponsoring this study.
• People who, in the opinion of the investigating doctor, have any condition or situation that could put them at significant risk, affect the study results, or interfere with their ability to participate.

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