Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Last updated: July 25, 2023
Sponsor: VisionCare, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Geographic Atrophy

Aging

Treatment

SING IMT(TM) System, model NG SI IMT 3X

Clinical Study ID

NCT04796545
SING IMT PMCF
  • Ages > 55
  • All Genders

Study Summary

The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD).

Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be 55 years of age or older.
  2. Have retinal findings of geographic atrophy or disciform scar with foveal involvementas determined by fluorescein angiography or OCT.
  3. Have evidence of cataract.
  4. Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR)and no worse than 20/800 (1.6 LogMAR) in both eyes.
  5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed byobservation of ambulation.
  6. Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled forsurgery when using Samsara's 2.8X external telescope simulator (ETS, suppliedseparately).
  7. Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
  8. Be willing to participate in a post-operative training program for the use of the NGSI IMT 3X implant.
  9. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
  10. Have adequate understanding of the local language to understand verbal and writtensubject information and be willing to comply with the study requirements.

Exclusion

Exclusion Criteria:

  1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography orOCT or were treated for CNV within the past six months.
  2. Any ophthalmic pathology that compromises the patient's peripheral vision in thefellow eye.
  3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperativeIOP>22 mm Hg.
  4. Corneal guttata.
  5. Known sensitivity to post-operative medications.
  6. Significant communication impairment or severe neurological disorders.
  7. Have undergone previous intraocular or corneal surgery of any kind in the operativeeye, including any type of surgery for either refractive or therapeutic purposes.
  8. An ocular condition that predisposes the patient to eye rubbing.
  9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3Ximplant surgery.
  10. Patients for whom the planned operative eye has:
  • Myopia > 6.0 D
  • Hyperopia > 4.0 D
  • Axial length < 21 mm
  • Endothelial cell density < 1600 cells per square mm
  • Narrow angle, i.e., < Schaffer grade 2.
  1. Inflammatory ocular disease.
  2. Cornea stromal or endothelial dystrophies, including guttata.
  3. Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
  4. Diabetic retinopathy.
  5. Untreated retinal tears.
  6. Retinal vascular disease.
  7. Optic nerve disease.
  8. A history of retinal detachment.
  9. Retinitis pigmentosa.
  10. Intraocular tumor.
  11. Have received any investigational product within 30 days prior to study enrollment orbe planning to participate in another investigation during the course of this study.
  12. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
  13. Have a condition or be in a situation that, in the Investigator's opinion, may put theSubject at significant risk, may confound the study results, or may interferesignificantly with the Subject's participation in the study.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: SING IMT(TM) System, model NG SI IMT 3X
Phase:
Study Start date:
September 13, 2022
Estimated Completion Date:
December 31, 2028

Study Description

This is an interventional, prospective, multicenter, open label, single group assignment Post-Market Clinical Follow-up (PMCF) study in men and women >=55 years with central vision impairment associated with end-stage AMD.

Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study. Baseline visual acuity of the study subjects will be assessed with a 2.8X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts to determine if they are likely to benefit from receiving the IMT. To be included in the study and to proceed with the surgery, subjects must achieve, using the ETS, at least a one line (5 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery. Subjects not meeting these criteria will be excluded from the study.

If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery.

Postoperatively, the surgeon will complete a usability and satisfaction questionnaire after each implantation procedure.

The patients will undergo ophthalmic evaluations in both eyes at regular intervals for up to 12 months. The subjects will also be required to undergo 6 to 10 additional visits for vision training with a low vision specialist.

Surgical complications, as well as all Adverse Event (AEs) and use of medications will be monitored from baseline to the end of the study.

Connect with a study center

  • Augenklinik Städtisches Klinikum Karlsruhe

    Karlsruhe,
    Germany

    Terminated

  • Universitätsklinikum Münster Klinik für Augenheilkunde

    Münster,
    Germany

    Site Not Available

  • Mater Misericordiae University Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • Università degli Studi di Napoli Federico II

    Napoli,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Active - Recruiting

  • VISSUM

    Alicante,
    Spain

    Active - Recruiting

  • Institut OMIQ

    Barcelona,
    Spain

    Active - Recruiting

  • Royal Victoria Hospital Belfast Health & Social Care Trust

    Belfast,
    United Kingdom

    Site Not Available

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