Health TrialsbyHealthPanel

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

ConditionAge - Related Macular Degeneration (AMD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorVisionCare, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lens-Exchange

    Procedure/Surgery

    The existing IOL will be removed and replaced by implanting SING IMT™ device in the sulcus

  • Add-on

    Procedure/Surgery

    The SING IMT™ device will be placed in front of the existing IOL and implanted in the sulcus.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Lens Exchange groupExperimental treatment 1 intervention
Group B: Add-OnExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incision size required for device implantation

measurement of the incision size

Time frame
baseline
2

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
3

Acuity

Change in near and distance best corrected acuity in implanted eyes

Time frame
at baseline, then at 1, 3 and 6 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VisionCare, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now