International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study

NCT07164378 | Recruiting

• 1 other identifier: PKCIP-01.0
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 12

Brief Summary

This study aims to expand the CE mark IFU of the SING IMT™ to pseudophakic (patients with an intraocular lents) patients with late stage of AMD (Age-Related Macular Degeneration) and bilateral central vision impairment. This randomized, international, multicenter study will evaluate the safety and efficacy of the device in this patient group. Findings will support regulatory submissions, clinical decision-making, and potential label expansion.

Conditions

Age - Related Macular Degeneration (AMD)

Keywords

Sulcus; AMD; Age-related Macular Degeneration; IOL; Intra-Ocular Lens; Pseudophakic; Samsara Vision; Add-on; SINGIMT; lens-exchange

Outcome Measures

Primary Outcomes (1)

• percentage of ECD loss

  assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%

  at baseline, then at 1, 3 and 6 months

Secondary Outcomes (4)

• Incision size required for device implantation

  baseline

• Number of Surgical Complications, AEs and SAEs

  at baseline, then at 1, 3 and 6 months

• Acuity

  at baseline, then at 1, 3 and 6 months

• Patient-reported outcomes

  at baseline, then at 1, 3 and 6 months

Study Arms (2)

Lens Exchange group

EXPERIMENTAL

SING IMT™ implantation in the sulcus after removal of the previously implanted IOL

Procedure: Lens-Exchange

Add-On

EXPERIMENTAL

SING IMT™ implantation in the sulcus in front of an existing IOL

Procedure: Add-on

Interventions

Add-on PROCEDURE

The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.

Add-On

Lens-Exchange PROCEDURE

The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus

Lens Exchange group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 55 years of age or older;
• Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes;
• Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment;
• BCDVA no better than 20/80 and no worse than 20/800 in both eyes.
• Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
• Achieve using the ETS, at least 2-lines (10 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery.
• Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes.
• Have an ECD of at least 1600 cells per square mm in both eyes.
• Be willing to participate in a postoperative training program for the use of the SING IMT™ implant.
• Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed.
• Patient is registered with the national social security or equivalent in the country where consent is signed
• A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• , Not a woman of childbearing potential (WOCBP): A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through to the end of the study

You may not qualify if:

• A. Bilateral Ocular Conditions (affecting both eyes):
• Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months.
• Diabetic retinopathy.
• Retinal vascular diseases.
• History of retinal detachment.
• Retinitis pigmentosa.
• Intraocular tumor.
• Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata.
• Patient predisposing to eye rubbing
• B. Surgical Eye Conditions:
• Narrow angle (i.e., \< Schaffer grade 2).
• Axial length \<21 mm or \>26 mm.
• Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis.
• Plate haptic shape IOL implanted.
• Vitrectomized eye.

Sponsors & Collaborators

• VisionCare, Inc.: lead

Study Sites (12)

Centre d'Ophtalmologie Paradis-Monticelli

Marseille, France

RECRUITING

Hélios Ophtalmologie

Saint-Jean-de-Luz, France

RECRUITING

CHU de Strasbourg

Strasbourg, France

RECRUITING

Asklepios Augenklinik Nord-Heidberg

Hamburg, Germany

RECRUITING

Augenklinik Sulzbach

Sulzbach, Germany

RECRUITING

MVZ Augenklinik Petrisberg GmbH

Trier, Germany

RECRUITING

Augenklinik und Poliklinik des Universitätsklinikums

Würzburg, Germany

RECRUITING

Ospedale Generale Regionale "F. Miulli"

Bari, Italy

RECRUITING

IRCCS Humanitas

Bergamo, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

RECRUITING

Presidio Ospedaliero Palagi

Florence, Italy

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Faustino Vidal Aroca

CONTACT

+39 3476255836; fvidalaroca@samsaravision.com

Waza Hadjebi

CONTACT

infos@centclin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 10, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); DE (4); FR (3)