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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus
The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.
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
...and 1 more locations
percentage of ECD loss
assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%
Time frame: at baseline, then at 1, 3 and 6 months
Incision size required for device implantation
measurement of the incision size
Time frame: baseline
Number of Surgical Complications, AEs and SAEs
Assess number of safety events comparing to similar procedures.
Time frame: at baseline, then at 1, 3 and 6 months
Acuity
Change in near and distance best corrected acuity in implanted eyes
Time frame: 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: 1. Vision-related quality of life Average of all items (ranging from 0 to 2.9) 2. Reading and accessing information Average of (Q1, Q3, Q5, Q6, Q7, Q8, Q9, Q14, Q15), (ranging from 0 to 2.7) 3. Mobility and Independence Average of (Q2, Q4, Q10, Q11, Q12, Q13, Q16, Q17, Q18, Q19, Q20), (ranging from 0 to 3) 4. Emotional well-being Average of (Q21, Q22, Q23, Q24, Q25, Q26, Q27, Q28), (ranging from 0 to 3)
Time frame: at baseline, then at 1, 3 and 6 months
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