Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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We present a prospective study of a cohort of patients with age-related macular degeneration and myopic maculopathy treated with SML implantation. The study was approved by the ethics committee at the Consorci Sanitari de Terassa (Barcelona, Spain). Patients will be examined for best corrected visual acuity prior to the surgery at 6 meter and for reading at 40cm (with a +2.5D) and 15 cm (with +6D). Improvement of the reading ability at 15 cm compared to 40 cm will predict the potential for vision improvement with the add on lens. The preoperative and postoperative assessment will include a full ophthalmological exam, visual acuity for distance and near, optical coherence tomography of the anterior chamber and of the macula, axial length and keratometry examination using biometry and VFQ25 questionnaire. Postoperative assessment will be performed at day 1, 1 week, 1, 3 and 6 months after surgery.

Official Title
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Near Visual Acuity and Quality of Life Improvement After Implantation of the add-on Scharioth Macula Lens (SML, Medicontur) in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy

Conditions
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Age-Related Macular Degeneration, Lens, Intraocular, Myopic Maculopathy

Intervention / Treatment
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* Device: Scharioth Macula Lens (SML, Medicontur)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SML implantation<br>prospective study of a cohort of patients with age-related macular degeneration or myopic maculopathy treated with SML implantation | Device: Scharioth Macula Lens (SML, Medicontur)<br>* magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in near visual acuity | to compare the near visual acuity before and after the SML implantation | will be performed at day 1, 1 week, 1, 3 and 6 months after surgery | 
| change in VFQ25 score | to compare the VFQ25 score before and after the SML implantation | will be performed at day 1, 1 week, 1, 3 and 6 months after surgery | 
| change in far visual acuity | to compare the far visual acuity before and after the SML implantation | will be performed at day 1, 1 week, 1, 3 and 6 months after surgery |