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

Sponsor
Consorci Sanitari de Terrassa (Other)
Overall Status
Unknown status
CT.gov ID
NCT03882606
Collaborator
Medicontur Medical Engineering Ltd (Industry)
10
Enrollment
1
Location
1
Arm
12.4
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Scharioth Macula Lens (SML, Medicontur)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
May 22, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in near visual acuity [will be performed at day 1, 1 week, 1, 3 and 6 months after surgery]

    to compare the near visual acuity before and after the SML implantation

  2. change in VFQ25 score [will be performed at day 1, 1 week, 1, 3 and 6 months after surgery]

    to compare the VFQ25 score before and after the SML implantation

  3. change in far visual acuity [will be performed at day 1, 1 week, 1, 3 and 6 months after surgery]

    to compare the far visual acuity before and after the SML implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Consorci Sanitari de Terrassa Terrassa Barcelona (spain) Spain 08227

Sponsors and Collaborators

  • Consorci Sanitari de Terrassa
  • Medicontur Medical Engineering Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Gutiérrez-Benítez, MD, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT03882606
Other Study ID Numbers:
  • GUTSML201902
First Posted:
Mar 20, 2019
Last Update Posted:
May 3, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Macular Degeneration
Myopia

Study Results

No Results Posted as of May 3, 2019