Actively 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
Led by VisionCare, Inc. · Updated on 2026-03-20
44
Participants Needed
12
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 55 years of age or older
- Have late-stage Age-Related Macular Degeneration with geographic atrophy or disciform scar involving the fovea in both eyes
- Have had cataract surgery with intraocular lens implantation in both eyes at least 6 months before enrollment
- Best corrected distance visual acuity between 20/80 and 20/800 in both eyes
- Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation
- Achieve at least 2 lines (10 or more letters) improvement in distance vision on the ETDRS chart in the eye scheduled for surgery
- Have an anterior chamber depth of at least 2.5 mm in both eyes
- Have endothelial cell density of at least 1600 cells per square millimeter in both eyes
- Be willing to participate in a postoperative training program for using the SING IMT12 implant
- Review and sign the informed consent form prior to any study procedures
- Be registered with the national social security or equivalent in the country where consent is signed
- If female, not pregnant, not breastfeeding, and either not of childbearing potential or agrees to follow contraceptive guidance from screening through study end
You will not qualify if you...
- Evidence of active choroidal neovascularization or treatment for it within the past 6 months
- Diabetic retinopathy
- Retinal vascular diseases
- History of retinal detachment
- Retinitis pigmentosa
- Intraocular tumor
- Corneal stromal or endothelial dystrophies such as corneal guttata
- Predisposition to eye rubbing
- Narrow angle less than Schaffer grade 2
- Axial eye length less than 21 mm or greater than 26 mm
- History or current ocular or intraocular inflammation, infection, or edema including uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis
- Plate haptic shape intraocular lens implanted
- Vitrectomized eye
- Zonular weakness, instability, or pseudoexfoliation
- Iris abnormalities including pigment dispersion syndrome, aniridia, or iris neovascularization
- Any intraocular lens already implanted in the sulcus
- Presence of toric or multifocal intraocular lens types
- Optic nerve disease
- History of uncontrolled steroid-induced intraocular pressure elevation, glaucoma, or preoperative intraocular pressure over 22 mmHg
- Known sensitivity to postoperative medications
- Significant communication impairment or severe neurological disorders
- Use of investigational products within 30 days before enrollment or planned participation in another clinical trial during this study
- Any condition that poses significant risk, confounds results, or interferes with study participation
- Individuals under legal care unable to understand and provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
Actively Recruiting
2
Hélios Ophtalmologie
Saint-Jean-de-Luz, France
Actively Recruiting
3
CHU de Strasbourg
Strasbourg, France
Actively Recruiting
4
Asklepios Augenklinik Nord-Heidberg
Hamburg, Germany
Actively Recruiting
5
Augenklinik Sulzbach
Sulzbach, Germany
Actively Recruiting
6
MVZ Augenklinik Petrisberg GmbH
Trier, Germany
Actively Recruiting
7
Augenklinik und Poliklinik des Universitätsklinikums
Würzburg, Germany
Actively Recruiting
8
Ospedale Generale Regionale "F. Miulli"
Bari, Italy
Actively Recruiting
9
IRCCS Humanitas
Bergamo, Italy
Actively Recruiting
10
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Actively Recruiting
11
Presidio Ospedaliero Palagi
Florence, Italy
Actively Recruiting
12
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy
Actively Recruiting
Research Team
F
Faustino Vidal Aroca
CONTACT
W
Waza Hadjebi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here