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

NCT03882606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Scharioth Macula Lens (SML, Medicontur)

magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient

Sponsors & Collaborators

  • Medicontur Medical Engineering Ltd

    collaborator INDUSTRY

  • Consorci Sanitari de Terrassa

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882606 on ClinicalTrials.gov