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Clinical Trials in Germany / NCT07164378
Recruiting Not applicable

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 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-09-23
Last updated
2026-03-20

Condition(s) studied

Age - Related Macular Degeneration (AMD)

Investigational drug(s) / intervention(s)

Lens-ExchangeAdd-on

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

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

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Be 55 years of age or older; 2. Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes; 3. Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment; 4. BCDVA no better than 20/80 and no worse than 20/800 in both eyes. 5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation. 6. 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. 7. Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes. 8. Have an ECD of at least 1600 cells per square mm in both eyes. 9. Be willing to participate in a postoperative training program for the use of the SING IMT™ implant. 10. Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed. 11. Patient is registered with the national social security or equivalent in the country where consent is signed 12. A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 13, 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 Exclusion Criteria: A. Bilateral Ocular Conditions (affecting both eyes): 1. Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months. 2. Diabetic retinopathy. 3. Retinal vascular diseases. 4. History of retinal detachment. 5. Retinitis pigmentosa. 6. Intraocular tumor. 7. Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata. 8. Patient predisposing to eye rubbing B. Surgical Eye Conditions: 9. Narrow angle (i.e., \< Schaffer grade 2). 10. Axial length \<21 mm or \>26 mm. 11. Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis. 12. Plate haptic shape IOL implanted. 13. Vitrectomized eye. 14. Zonular weakness, instability, presence of pseudoexfoliation. 15. Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization. 16. Any IOL already implanted in the sulcus. 17. Presence of toric or multifocal IOL types. 18. Optic Nerve Disease C. Systemic or Other General Conditions: 19. A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP \>22 mmHg. 20. Known sensitivity to post-operative medications. 21. Significant communication impairment or severe neurological disorders. 22. Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study. 23. Any condition or situation that, in the opinion of the investigator, may: * Put the subject at significant risk, * Confound the clinical investigation results, or * Interfere significantly with the subject's participation in the study. 24. Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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

More VisionCare, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164378 on ClinicalTrials.gov ↗ ← All trials in Germany