Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With En… (NCT04796545) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
Belgium, France, Germany76 participantsStarted 2022-09-13
Plain-language 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.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. Be 55 years of age or older.
✓. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as 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 by observation of ambulation.
✓. Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
✓. 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 NG SI IMT 3X implant.
Exclusion criteria
✕. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
What they're measuring
1
Safety of the SING IMT System, model NG SI IMT 3X, including its delivery system
✕. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
✕. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>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 operative eye, including any type of surgery for either refractive or therapeutic purposes.
✕. An ocular condition that predisposes the patient to eye rubbing.