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 18 years of age or older at the time of joining the trial
• People who have a confirmed diagnosis of an inherited condition causing the retina to break down, affecting the central part of the eye (macula) in both eyes
• People whose vision in the eye being studied is very poor — roughly 20/320 or worse on a standard eye chart
• People who have a specific area of damage in the central part of the retina in the eye being studied that is large enough to fit the implant (at least 4.5 mm² in area and at least 2.4 mm across)
• People who are willing and able to attend all required follow-up appointments as scheduled
• People who have read and signed the official consent form for the trial

Who may not be able to join:

• People who have cataracts in the eye being studied above a certain severity level (the trial site can provide further detail on this threshold)
• People who had a lens implanted in the eye being studied within the last 4 weeks before joining
• People who already have an artificial lens in the eye being studied and whose prescription falls outside a certain range (confirm with trial site)
• People whose eye being studied is highly elongated (longer than 26 mm from front to back)
• People who have no ability to detect any light at all in either eye
• People who have a history of abnormal blood vessel growth under the retina (choroidal neovascularisation) in either eye
• People who have signs of a "wet" form of macular degeneration, including fluid-related changes in the central area of the eye being studied
• People who already have a miniature telescope implanted in one eye
• People who have a black-coloured artificial lens in the eye being studied
• People who have another eye or vision condition (other than the one that qualifies them for the trial) that affects how the eye being studied works — for example, blocked blood vessels, advanced diabetic eye disease, retinal detachment, severe glaucoma, or inflammation of the retina (confirm with trial site for the full list)
• People who have any condition that prevents the eye being studied from being properly examined using standard equipment, including scans of the retina
• People who have a low cell count in the inner layer of the cornea of the eye being studied (fewer than 1,000 cells per mm²)
• People who have uncontrolled or involuntary eye movements (such as nystagmus) or other movement disorders affecting the eyes
• People who have a condition that would prevent them from understanding the trial requirements or communicating clearly — for example, severe neurological conditions or profound hearing loss (confirm with trial site)
• People who have epileptic seizures that are not well controlled
• People who have a known sensitivity to any of the materials used in the implant (iridium oxide, silicon carbide, or titanium)
• People who have a known allergy to anaesthetic medications
• People whose eye pressure in the eye being studied is too low (below 8 mmHg)
• People whose eye pressure in the eye being studied remains too high (above 23 mmHg) even with treatment
• People who currently have cancer, or who have a history of cancer affecting the eye, optic nerve, or brain, including any spread of cancer to those areas
• People whose immune system is suppressed, for example due to HIV
• People who are known carriers of highly drug-resistant bacteria or microorganisms
• People taking blood-thinning medications that cannot be safely adjusted to allow eye surgery
• People currently participating in another clinical trial of an investigational drug or device that could interfere with this trial
• People with a history of repeated or ongoing infections or inflammation that would make participation unsafe
• People with serious ongoing or recurring inflammation or infection — including certain chronic diseases (such as Crohn's disease or Whipple's disease) or active eye area infections (such as recurring eyelid or conjunctival infections, herpes of the eye, styes, or eyelid cysts)
• People who have a severe psychological disorder
• People who do not have the legal mental capacity to sign a consent form
• People with severe organ disease affecting the heart, kidneys, liver, or similar (classified as ASA IV or worse — confirm with trial site)
• People whose head shape or size is not compatible with the special glasses that are part of this trial's system
• People who have expectations about the outcome that the investigator considers unrealistic — for example, believing that a successful result is guaranteed or expecting fully normal vision after surgery
• People who have physical limitations that would make it impossible to use the device or complete the rehabilitation programme
• People who, in the opinion of the investigator, are not suitable for the trial for any other reason

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