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
NCT ID: NCT07164378
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2025-09-30
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lens Exchange group
SING IMT™ implantation in the sulcus after removal of the previously implanted IOL
Lens-Exchange
The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus
Add-On
SING IMT™ implantation in the sulcus in front of an existing IOL
Add-on
The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
55 Years
ALL
No
Sponsors
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VisionCare, Inc.
INDUSTRY
Responsible Party
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Locations
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Centre d'Ophtalmologie Paradis-Monticelli
Marseille, , France
Hélios Ophtalmologie
Saint-Jean-de-Luz, , France
CHU de Strasbourg
Strasbourg, , France
Asklepios Augenklinik Nord-Heidberg
Hamburg, , Germany
Augenklinik Sulzbach
Sulzbach, , Germany
Augenklinik und Poliklinik des Universitätsklinikums
Würzburg, , Germany
Ospedale Generale Regionale "F. Miulli"
Bari, , Italy
IRCCS Humanitas
Bergamo, , Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, , Italy
Presidio Ospedaliero Palagi
Florence, , Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, , Italy
Countries
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Central Contacts
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Other Identifiers
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PKCIP-01.0
Identifier Type: -
Identifier Source: org_study_id
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