Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
VisionCare, Inc.
Conditions:
Age - Related Macular Degeneration (AMD)
Eligibility:
All Genders
55+ years
Phase:
NA
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...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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:
- 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
- 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:
- Put the subject at significant risk,
- Confound the clinical investigation results, or
- Interfere significantly with the subject's participation in the study.
- Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07164378
Start Date
September 30 2025
End Date
April 30 2027
Last Update
September 10 2025
Active Locations (11)
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1
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
2
Hélios Ophtalmologie
Saint-Jean-de-Luz, France
3
CHU de Strasbourg
Strasbourg, France
4
Asklepios Augenklinik Nord-Heidberg
Hamburg, Germany