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

NCT03882606 | Completed

• 1 other identifier: GUTSML201902
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

SML implantation

OTHER

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)

Interventions

Scharioth Macula Lens (SML, Medicontur) DEVICE

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

SML implantation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Medicontur Medical Engineering Ltd: collaborator

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona (spain), 08227, Spain

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 20, 2019
• Study Start: May 22, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 17, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)