Age-Related Macular DegenerationNCT03882606
Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy
A study testing Scharioth Macula Lens (SML, Medicontur) in people with Age-Related Macular Degeneration and Lens, Intraocular, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Lens, Intraocular, Myopic Maculopathy
- What is being tested?
- Scharioth Macula Lens (SML, Medicontur)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- 22 May 2019to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Scharioth Macula Lens (SML, Medicontur)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scharioth Macula Lens (SML, Medicontur)Device
magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient
| Study group | Role | What they receive |
|---|---|---|
| SML implantation | Other | prospective study of a cohort of patients with age-related macular degeneration or myopic maculopathy treated with SML implantation Receives: Device: Scharioth Macula Lens (SML, Medicontur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in near visual acuity
to compare the near visual acuity before and after the SML implantation
Measured: 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
Measured: 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
Measured: will be performed at day 1, 1 week, 1, 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start22 May 2019
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Medicontur Medical Engineering Ltd
- Responsible party
- Principal investigator, Laura Gutiérrez-Benítez, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882606
- Sponsor's protocol ID
- GUTSML201902
- Status last verified
- Sep 2023
- First submitted
- 22 Feb 2019
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03882606
- Acronym / sponsor ID
- GUTSML201902
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Medicontur Medical Engineering Ltd
- Study start
- 22 May 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SML implantation | Other | Device: Scharioth Macula Lens (SML, Medicontur)prospective study of a cohort of patients with age-related macular degeneration or myopic maculopathy treated with SML implantation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- complicated cataract surgery
- excessive zonular weakness
- chronic uveitis
- active rubeosis iridis
- central corneal opacities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scharioth Macula Lens (SML, Medicontur)magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient | Device | SML implantation |
Primary outcome
change in near visual acuity
Time frame: 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
change in VFQ25 score
Time frame: 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
change in far visual acuity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scharioth Macula Lens (SML, Medicontur) in people with Age-Related Macular Degeneration and Lens, Intraocular, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in near visual acuity (time frame: will be performed at day 1, 1 week, 1, 3 and 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.