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Prospective, Multicenter, Randomized International Study of the SING IMT™ Prosthesis in Pseudophakic Patients With Moderate to Profound Bilateral Central Vision Impairment Due to Advanced Age-Related Macular Degeneration
Led by VisionCare, Inc. · Updated on 2026-03-20
44
Participants Needed
12
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the SING IMT™ prosthesis in patients aged 55 and older who have pseudophakic eyes (eyes with implanted intraocular lenses) and suffer from late-stage Age-Related Macular Degeneration (AMD) with moderate to profound bilateral central vision impairment. This international, randomized, multicenter study aims to expand the device's approved use and assess its safety and effectiveness in this specific patient group. The findings will support regulatory decisions, help clinical care, and may lead to label expansion for the device. The study involves two treatment approaches: one where the SING IMT™ device replaces the existing intraocular lens (IOL) after removal (Lens Exchange group), and another where the device is implanted in front of the existing IOL without removal (Add-On group). Both procedures place the device in the sulcus area of the eye. Participants will be randomly assigned to one of these two groups. The trial includes multiple follow-up periods to assess outcomes after implantation. Participants will undergo vision tests and eye examinations at the start and then at 1, 3, and 6 months after the procedure. Key assessments include measuring the percentage of endothelial cell density (ECD) loss, visual acuity, and recording any surgical complications or adverse events. Patient-reported outcomes and the size of the incision needed for implantation will also be tracked. Participants are expected to engage in a postoperative training program for using the implant. The total study duration for each participant covers these assessments and monitoring visits.
CONDITIONS
Brief 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 center of both eyes
- Have had cataract surgery with intraocular lens implantation in both eyes at least 6 months before enrollment
- Have best corrected distance visual acuity (BCDVA) between 20/80 and 20/800 in both eyes
- Have adequate peripheral vision in the eye not scheduled for surgery
- Achieve at least 2-line improvement on distance vision test (ETS) in the eye scheduled for surgery
- Have an anterior chamber depth of at least 2.5 mm in both eyes
- Have an endothelial cell density (ECD) of at least 1600 cells/mm² in both eyes
- Be willing to participate in postoperative training for use of the SING IMT™ implant
- Provide informed consent by signing the approved consent form
- Be registered with national social security or equivalent in the country where consent is signed
- Women must not be pregnant or breastfeeding and either not be of childbearing potential or agree to use contraception from screening through study end
You will not qualify if you...
- Have active choroidal neovascularization or treatment for it within the past 6 months
- Have diabetic retinopathy
- Have retinal vascular diseases
- Have history of retinal detachment
- Have retinitis pigmentosa
- Have intraocular tumor
- Have corneal stromal or endothelial dystrophies, such as corneal guttata
- Be prone to eye rubbing
- Have narrow eye angle (less than Schaffer grade 2)
- Have axial eye length less than 21 mm or greater than 26 mm
- Have history or current ocular inflammation, infection, or edema (e.g., uveitis, iritis, keratitis)
- Have plate haptic shape intraocular lens implanted
- Have had vitrectomy
- Have zonular weakness, instability, or pseudoexfoliation
- Have iris abnormalities including pigment dispersion syndrome, aniridia, or iris neovascularization
- Have any intraocular lens already implanted in the sulcus
- Have toric or multifocal intraocular lens types
- Have optic nerve disease
- Have uncontrolled glaucoma, steroid-induced intraocular pressure elevation, or preoperative intraocular pressure above 22 mmHg
- Have known sensitivity to postoperative medications
- Have significant communication impairment or severe neurological disorders
- Have received any investigational product within 30 days or plan to participate in another trial during this study
- Have any condition that may put the subject at risk, confound results, or interfere with study participation
- Be under legal care and unable to provide informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery and recovery period until device implantation is complete
Participants undergo surgery to have the SING IMT™ device implanted either by replacing the existing intraocular lens or placing the device on top of the existing lens.
1 surgical visit
Duration - Up to 6 months after surgery
Participants are monitored for safety and outcomes including endothelial cell density, surgical complications, visual acuity, and patient-reported outcomes.
Visits at 1, 3, and 6 months post-surgery
Trial Site Locations
Total: 12 locations
1
Centre d'Ophtalmologie Paradis-Monticelli
Marseille, France
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2
Hélios Ophtalmologie
Saint-Jean-de-Luz, France
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3
CHU de Strasbourg
Strasbourg, France
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4
Asklepios Augenklinik Nord-Heidberg
Hamburg, Germany
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5
Augenklinik Sulzbach
Sulzbach, Germany
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6
MVZ Augenklinik Petrisberg GmbH
Trier, Germany
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7
Augenklinik und Poliklinik des Universitätsklinikums
Würzburg, Germany
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8
Ospedale Generale Regionale "F. Miulli"
Bari, Italy
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9
IRCCS Humanitas
Bergamo, Italy
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10
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
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11
Presidio Ospedaliero Palagi
Florence, Italy
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12
Policlinico Universitario Fondazione Agostino Gemelli
Roma, Italy
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Research Team
F
Faustino Vidal Aroca
W
Waza Hadjebi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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