Clinical Investigation of the Tsert SI System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
Study Details
Study Description
Brief Summary
The NG SI IMT (Next Generation Small Incision Implantable Miniature Telescope) 3X implant is intended to improve vision in patients with end-stage Age-related Macular Degeneration (AMD).
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. After signing an informed consent, subjects will be prescreened for eligibility in the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Baseline visual acuity of the study subjects will be assessed with a 2.7X external telescope simulator (ETS) using Early Treatment Diabetic Retinopathy Trial (ETDRS) charts. 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. Visual acuity must be at least one line (5 or more letters) better with the ETS than Best Corrected Visual Acuity (BCVA) in the fellow eye without the ETS. Subjects not meeting these criteria will be excluded from the study. Following this assessment, eligible subjects will undergo three pre-op visits with the low vision rehabilitation/training specialist prior to continuation of testing for inclusion in the study.
Once it will be determined that the subject experiences improvement in visual acuity with the use of the ETS, he/she will be further evaluated for eligibility, with near and distance BCVA, manifest refraction, intraocular pressure (IOP), slit lamp examination, non-contact specular microscopy (before or after home use of ETS), Anterior Chamber Depth (ACD) profile by Ultrasound Biomicroscopy (UBM), Optical Coherence Tomography (OCT), or another applicable test method, and axial eye length.
The participants will be implanted with the Tsert System model NG SI IMT 3X. 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 to determine the change in visual acuity and Endothelial Cell Density (ECD) in the both eyes. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tsert SI System model NG SI IMT 3X All participants will be implanted with the Tsert SI System model NG SI IMT 3X. |
Device: NG SI IMT 3X implant
The NG SI IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.
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Outcome Measures
Primary Outcome Measures
- Safety of the Tsert SITM System, model NG SI IMT 3X, including its delivery system [12 months]
The percent decrease in ECD.
Secondary Outcome Measures
- Incision size needed for device implantation [12 moths]
Incision size will not exceed 8.0 mm (non-inferiority assumption) in 75% of surgeries
- Surgical complications [12 moths]
AEs and serious adverse events
- Improvement in near and distance best corrected visual acuity (BCVA) in implanted eyes. [12 months]
Near and distance BCVA will show an improvement of ≥2 lines in the ETDRS chart in at least 50% (non-inferior to 50%) of the implanted eyes at 12 months post implantation.
- Usability of Tsert SITM System, including delivery system [12 months]
Surgeon will complete a usability and satisfaction questionnaire
Other Outcome Measures
- Device stability and fixation assessed by slit lamp bio-microscopy examination [12 months]
Device Tilt Device decentration
- Post-operative anterior chamber depth (ACD) [12 months]
Anterior Chamber Depth (ACD) evaluated by ultrasound bio-microscopy (UBM), OCT or another applicable test method
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be 55 years of age or older.
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Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography.
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Have evidence of cataract.
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Have BCDVA no better than 20/80 and no worse than 20/800 in both eyes.
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Have adequate peripheral vision in the eye not scheduled for surgery.
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Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using VisionCare's 3X ETS (supplied separately).
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Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
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Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
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Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
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Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.
Exclusion Criteria:
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Evidence of active CNV on fluorescein angiography or were treated for CNV within the past six months.
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Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
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A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP>22 mm Hg.
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Corneal guttata.
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Known sensitivity to post-operative medications.
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Significant communication impairment or severe neurological disorders.
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Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
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An ocular condition that predisposes the patient to eye rubbing.
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Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
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Patients for whom the planned operative eye has:
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Myopia > 6.0 D
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Hyperopia > 4.0 D
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Axial length < 21 mm
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Endothelial cell density < 1600 cells per square mm
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Narrow angle, i.e., < Schaffer grade 2.
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Inflammatory ocular disease.
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Cornea stromal or endothelial dystrophies, including guttata.
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Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
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Diabetic retinopathy.
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Untreated retinal tears.
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Retinal vascular disease.
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Optic nerve disease.
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A history of retinal detachment.
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Retinitis pigmentosa.
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Intraocular tumor.
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Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
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Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
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Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- VisionCare, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tsert SI PMCF