Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy (NCT03882606) | Clinical Trial Compass
CompletedNot Applicable
Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy
Spain3 participantsStarted 2019-05-22
Plain-language summary
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in developed countries among people over 50 years of age. Myopic maculopathy is also an important cause of irreversible vision loss. Reduced near visual acuity is still a major problem with all forms of AMD and myopic maculopathy. Various intraocular lenses for near vision (IOLs) or telescopic systems have been described but are not widely accepted and almost all solutions require phakic status of the eye and are implanted during cataract surgery. Therefore, these devices are not appropriated for pseudophakic AMD and myopic maculopathy patients. Scharioth Macula Lens (SML, Medicontur) is a magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient. The implant has a bifocal optic, with a central 1.5mm diameter optical zone equivalent to +10D add and a peripheral zone optically neutral. The implantation of the add-on SML can improve the near visual acuity of pseudophakic patients with AMD and myopic maculopathy without impairing their distance visual acuity.
The principal objective is to compare the near visual acuity, the far visual acuity and the self-reported vision health status before and after the SML implantation.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eye with better distance visual acuity or non-dominant eye in case of equal visual acuity in both eyes
* Best corrected visual acuity 0.1-0.4 (Snellen)
* Pseudophakia
* Preoperative testing of corrected near visual acuity (CNVA) at 15cm (+6 D) better than CNVA at 40 cm (+2.5D)
* understand the principle of this implant (reduced reading distance, maximum magnification)
* signing the informed consent
Exclusion Criteria:
* complicated cataract surgery
* excessive zonular weakness
* chronic uveitis
* active rubeosis iridis
* central corneal opacities
* inability to understand the principle of this implant (reduced reading distance, maximum magnification)
* Narrow anterior chamber (\<2.8mm)
* Narrow angle
* glaucoma
* Phakic
* Current treatment with intravitreal injections
* active maculopathy
* atrophy
* photopic pupil size less than 2.5 mm
* severe eye pathology
* previous retinal surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in near visual acuity
Timeframe: will be performed at day 1, 1 week, 1, 3 and 6 months after surgery
2
change in VFQ25 score
Timeframe: will be performed at day 1, 1 week, 1, 3 and 6 months after surgery
3
change in far visual acuity
Timeframe: will be performed at day 1, 1 week, 1, 3 and 6 months after surgery