Age - Related Macular Degeneration (AMD)PERSPECTIVENCT07164378
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
A study testing Lens-Exchange and Add-on in people with Age - Related Macular Degeneration (AMD), run by VisionCare, Inc. at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age - Related Macular Degeneration (AMD)
- What is being tested?
- Lens-Exchange and Add-on
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 23 Sep 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- Intraocular tumor.
- Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata.
- Patient predisposing to eye rubbing
- 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
- 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.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Waza Hadjebi contact
12 sites in 3 countries
Italy5 sites, 5 recruiting
- Recruiting
Ospedale Generale Regionale "F. Miulli"
Bari
- Recruiting
IRCCS Humanitas
Bergamo
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
- Recruiting
Presidio Ospedaliero Palagi
Florence
- Recruiting
Policlinico Universitario Fondazione Agostino Gemelli
Roma
Germany4 sites, 4 recruiting
- Recruiting
Asklepios Augenklinik Nord-Heidberg
Hamburg
- Recruiting
Augenklinik Sulzbach
Sulzbach
- Recruiting
MVZ Augenklinik Petrisberg GmbH
Trier
- Recruiting
Augenklinik und Poliklinik des Universitätsklinikums
Würzburg
France3 sites, 3 recruiting
- Recruiting
Centre d'Ophtalmologie Paradis-Monticelli
Marseille
- Recruiting
Hélios Ophtalmologie
Saint-Jean-de-Luz
- Recruiting
CHU de Strasbourg
Strasbourg
About this study
Official title: 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
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.
Read the 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
- Age - Related Macular Degeneration (AMD)
- Being tested
- Lens-Exchange, Add-on
- Keywords
- Sulcus, AMD, Age-related Macular Degeneration, IOL, Intra-Ocular Lens, Pseudophakic, Samsara Vision, Add-on, SINGIMT, lens-exchange
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens-ExchangeProcedure or surgery
The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus
Add-onProcedure or surgery
The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.
| Study group | Role | What they receive |
|---|---|---|
| Lens Exchange group | Experimental | SING IMT™ implantation in the sulcus after removal of the previously implanted IOL Receives: Procedure: Lens-Exchange |
| Add-On | Experimental | SING IMT™ implantation in the sulcus in front of an existing IOL Receives: Procedure: Add-on |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of ECD loss
assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%
Measured: at baseline, then at 1, 3 and 6 months
Secondary outcomes (4)
Incision size required for device implantation
measurement of the incision size
Measured: baseline
Number of Surgical Complications, AEs and SAEs
Assess number of safety events comparing to similar procedures.
Measured: at baseline, then at 1, 3 and 6 months
Acuity
Change in near and distance best corrected acuity in implanted eyes
Measured: 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:
- Vision-related quality of life Average of all items (ranging from 0 to 2.9)
- Reading and accessing information Average of (Q1, Q3, Q5, Q6, Q7, Q8, Q9, Q14, Q15), (ranging from 0 to 2.7)
- Mobility and Independence Average of (Q2, Q4, Q10, Q11, Q12, Q13, Q16, Q17, Q18, Q19, Q20), (ranging from 0 to 3)
- Emotional well-being Average of (Q21, Q22, Q23, Q24, Q25, Q26, Q27, Q28), (ranging from 0 to 3)
Measured: at baseline, then at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start23 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age - Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164378
- Sponsor's protocol ID
- PKCIP-01.0
- Acronym
- PERSPECTIVE
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07164378
- Acronym / sponsor ID
- PERSPECTIVE / PKCIP-01.0
- Conditions
- Age - Related Macular Degeneration (AMD)
- Keywords
- Sulcus, AMD, Age-related Macular Degeneration, IOL, Intra-Ocular Lens, Pseudophakic, Samsara Vision, Add-on
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens Exchange group | Experimental | Procedure: Lens-ExchangeSING IMT™ implantation in the sulcus after removal of the previously implanted IOL |
| Add-On | Experimental | Procedure: Add-onSING IMT™ implantation in the sulcus in front of an existing IOL |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lens-ExchangeThe existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus | Procedure or surgery | Lens Exchange group |
| Add-onThe SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus. | Procedure or surgery | Add-On |
Primary outcome
percentage of ECD loss
Time frame: at baseline, then at 1, 3 and 6 months
assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%
4 secondary outcomes
Incision size required for device implantation
Time frame: baseline
Number of Surgical Complications, AEs and SAEs
Time frame: at baseline, then at 1, 3 and 6 months
Acuity
Time frame: at baseline, then at 1, 3 and 6 months
Patient-reported outcomes
Time frame: at baseline, then at 1, 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Waza Hadjebi contact
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens-Exchange and Add-on in people with Age - Related Macular Degeneration (AMD), run by VisionCare, Inc. at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faustino Vidal Aroca (+39 3476255836, fvidalaroca@samsaravision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of ECD loss (time frame: at baseline, then at 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.