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NCT03882606
Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic Maculopathy
NA trial testing Scharioth Macula Lens (SML, Medicontur) in Age-Related Macular Degeneration in 3 participants. Completed in 1 September 2023.
1 September 2023
Quick facts
| Lead sponsor | Consorci Sanitari de Terrassa |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 22 May 2019 |
| Primary completion | 1 September 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Scharioth Macula Lens (SML, Medicontur)
Conditions studied
- Age-Related Macular Degeneration — all drugs for Age-Related Macular Degeneration →
- Lens, Intraocular — all drugs for Lens, Intraocular →
- Myopic Maculopathy — all drugs for Myopic Maculopathy →
Sponsor
Consorci Sanitari de Terrassa — full company profile →
Who can join
50 and older, any sex, with Age-Related Macular Degeneration or Lens, Intraocular. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03882606
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Age-Related Macular Degeneration
Currently open trials in the same condition.
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- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06319872 — The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration · Phase 1 · recruiting
- NCT06662162 — Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration · NA · recruiting
Other Consorci Sanitari de Terrassa trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03882606 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Consorci Sanitari de Terrassa
- Last refreshed: 17 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03882606.
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