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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03882606
• Other study ID #: GUTSML201902
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2019
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: June 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Scharioth Macula Lens (SML, Medicontur)
magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona (spain)

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Medicontur

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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