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

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

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.

Study Overview

• Status: Unknown
• Conditions: Age-Related Macular Degeneration; Lens, Intraocular; Myopic Maculopathy
• Intervention / Treatment: Device: Scharioth Macula Lens (SML, Medicontur)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona (spain)
    • Terrassa, Barcelona (spain), Spain, 08227
      • Consorci Sanitari de Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SML implantation; 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); magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa
• Collaborators: Medicontur Medical Engineering Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): May 22, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Refractive Errors; Macular Degeneration; Myopia
• Other Study ID Numbers: GUTSML201902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No