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 at least 65 years old at the pre-surgery visit
• People whose vision in both eyes is severely reduced (roughly between 20/160 and 20/800 on an eye chart) due to blind spots in the centre of their vision caused by advanced age-related macular degeneration (AMD)
• People who have specific damage to both retinas — either geographic atrophy or scarring — involving the central part of the retina, confirmed by a specialised eye scan (fluorescein angiography)
• People who have been monitored by an eye care professional for at least 6 months before the pre-surgery visit, with no signs of active abnormal blood vessel growth (CNV) — meaning no treatment was needed for CNV in the past 6 months, no fluid build-up seen on retinal scans, and no bleeding in the retina during that period
• People who agree to take part in vision training after surgery
• For the eye that would receive the implant: people who have a visually significant cataract at the pre-surgery visit
• For the eye that would receive the implant: people who agree to complete pre-surgery training with a low vision specialist (optometrist or occupational therapist) using an external telescope model, and who show at least a 5-letter improvement in vision during that assessment
• For the eye that would not receive the implant: people who have enough side (peripheral) vision to move around safely

Who may not be able to join:

• People with cognitive difficulties that would prevent them from giving informed consent or completing the required vision training and rehabilitation
• People who have any of the following eye conditions: Stargardt macular dystrophy, diabetic retinopathy, untreated retinal tears, retinal vascular disease, optic nerve disease, a history of retinal detachment, a tumour inside the eye, or retinitis pigmentosa
• People with a history of eye pressure rising due to steroid use, uncontrolled glaucoma, or eye pressure above 22 mmHg at the pre-surgery visit
• People with a known allergy to medications used after eye surgery
• People with a history of rubbing their eyes, or an eye condition that causes eye rubbing
• People who have had, or are expected to have, other eye surgery within 30 days of the study surgery date
• People for whom the study doctor has safety concerns
• People with a systemic illness or medical condition that, in the study doctor's opinion, would make participation unsuitable
• People who are currently participating in, or have participated in, another clinical trial of a drug or device within the 30 days before the pre-surgery visit
• For the eye that would receive the implant: people whose eye has a front chamber depth of less than 3.0 mm
• For the eye that would receive the implant: people whose corneal cell density (the number of cells on the inner surface of the cornea) is below 2,000 cells per mm² (for those aged 65–84) or below 1,800 cells per mm² (for those aged 85 and older)
• For the eye that would receive the implant: people with a history of corneal layer disorders, including a condition called guttata
• For the eye that would receive the implant: people with a significant degree of short-sightedness (more than 6.0 D) or long-sightedness (more than 4.0 D)
• For the eye that would receive the implant: people whose eye length is less than 21 mm
• For the eye that would receive the implant: people with a narrow drainage angle in the eye (below grade 2 on the Schaffer scale)
• For the eye that would receive the implant: people with ongoing inflammatory eye disease at the pre-surgery visit
• For the eye that would receive the implant: people with weakness or instability of the structures holding the eye's natural lens in place, or a condition called pseudoexfoliation
• For the eye that would receive the implant: people whose eye anatomy, in the study doctor's judgement, would prevent the device from being correctly positioned during surgery
• For the eye that would receive the implant: people who have previously had any surgery inside the eye or on the cornea, including surgery for vision correction
• For the eye that would not receive the implant: people who have an eye condition that, in the study doctor's judgement, significantly affects their peripheral (side) vision

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