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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Be 55 years of age or older.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvementas determined by fluorescein angiography or OCT.
- Have evidence of cataract.
- 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.
- Have adequate peripheral vision in the eye not scheduled for surgery, assessed byobservation of ambulation.
- 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).
- Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
- Be willing to participate in a post-operative training program for the use of the NGSI IMT 3X implant.
- Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
- 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:
- Evidence of active choroidal neovascularization (CNV) on fluorescein angiography orOCT or were treated for CNV within the past six months.
- Any ophthalmic pathology that compromises the patient's peripheral vision in thefellow eye.
- A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperativeIOP>22 mm Hg.
- Corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
- Have undergone previous intraocular or corneal surgery of any kind in the operativeeye, including any type of surgery for either refractive or therapeutic purposes.
- An ocular condition that predisposes the patient to eye rubbing.
- Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3Ximplant surgery.
- 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.
- Inflammatory ocular disease.
- Cornea stromal or endothelial dystrophies, including guttata.
- Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
- Diabetic retinopathy.
- Untreated retinal tears.
- Retinal vascular disease.
- Optic nerve disease.
- A history of retinal detachment.
- Retinitis pigmentosa.
- Intraocular tumor.
- 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.
- Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
- 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
Connect with a study center
Augenklinik Städtisches Klinikum Karlsruhe
Karlsruhe,
GermanyTerminated
Universitätsklinikum Münster Klinik für Augenheilkunde
Münster,
GermanySite Not Available
Mater Misericordiae University Hospital
Dublin,
IrelandActive - Recruiting
Università degli Studi di Napoli Federico II
Napoli,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli
Roma,
ItalyActive - Recruiting
VISSUM
Alicante,
SpainActive - Recruiting
Institut OMIQ
Barcelona,
SpainActive - Recruiting
Royal Victoria Hospital Belfast Health & Social Care Trust
Belfast,
United KingdomSite Not Available
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