Trials / Recruiting
RecruitingNCT07164378
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
Prospective, MulticEnter, Randomized, 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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- VisionCare, Inc. · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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 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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Lens-Exchange | The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus |
| PROCEDURE | Add-on | The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus. |
Timeline
- Start date
- 2025-09-23
- Primary completion
- 2026-12-30
- Completion
- 2027-04-30
- First posted
- 2025-09-10
- Last updated
- 2026-03-20
Locations
12 sites across 3 countries: France, Germany, Italy
Source: ClinicalTrials.gov record NCT07164378. Inclusion in this directory is not an endorsement.