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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.
Eligible AMD patients with existing IOL on both eyes will be randomized to either have the SING-IMT device placed on top of the existing IOL, or to replace the existing IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens Exchange group | Experimental | SING IMT™ implantation in the sulcus after removal of the previously implanted IOL |
|
| Add-On | Experimental | SING IMT™ implantation in the sulcus in front of an existing IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens-Exchange | Procedure | The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incision size required for device implantation | measurement of the incision size | baseline |
| Number of Surgical Complications, AEs and SAEs | Assess number of safety events comparing to similar procedures. |
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Inclusion Criteria:
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):
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.
Zonular weakness, instability, presence of pseudoexfoliation.
Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization.
Any IOL already implanted in the sulcus.
Presence of toric or multifocal IOL types.
Optic Nerve Disease
C. Systemic or Other General Conditions:
A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP >22 mmHg.
Known sensitivity to post-operative medications.
Significant communication impairment or severe neurological disorders.
Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study.
Any condition or situation that, in the opinion of the investigator, may:
Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faustino Vidal Aroca | Contact | +39 3476255836 | fvidalaroca@samsaravision.com | |
| Waza Hadjebi | Contact | infos@centclin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Ophtalmologie Paradis-Monticelli | Recruiting | Marseille | France | |||
| Hélios Ophtalmologie |
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| Add-on | Procedure | The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus. |
|
| at baseline, then at 1, 3 and 6 months |
| Acuity | Change in near and distance best corrected acuity in implanted eyes | at baseline, then at 1, 3 and 6 months |
| Patient-reported outcomes | Using the Impact of Vision Impairment (IVI) questionnaire, 28 questions are answered, providing 4 different scores:
| at baseline, then at 1, 3 and 6 months |
| Recruiting |
| Saint-Jean-de-Luz |
| France |
| CHU de Strasbourg | Recruiting | Strasbourg | France |
| Asklepios Augenklinik Nord-Heidberg | Recruiting | Hamburg | Germany |
| Augenklinik Sulzbach | Recruiting | Sulzbach | Germany |
| MVZ Augenklinik Petrisberg GmbH | Recruiting | Trier | Germany |
| Augenklinik und Poliklinik des Universitätsklinikums | Recruiting | Würzburg | Germany |
| Ospedale Generale Regionale "F. Miulli" | Recruiting | Bari | Italy |
| IRCCS Humanitas | Recruiting | Bergamo | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara | Recruiting | Ferrara | Italy |
| Presidio Ospedaliero Palagi | Recruiting | Florence | Italy |
| Policlinico Universitario Fondazione Agostino Gemelli | Recruiting | Roma | Italy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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