[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VisionCare, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100605581","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-100605581",false,"NCT07164378","International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD \u002F PERSPECTIVE Study","Prospective, MulticEnter, Randomized, International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD \u002F PERSPECTIVE Study","PERSPECTIVE","Inclusion Criteria:\n\n1. Be 55 years of age or older;\n2. Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes;\n3. Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment;\n4. BCDVA no better than 20\u002F80 and no worse than 20\u002F800 in both eyes.\n5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.\n6. Achieve using the ETS, at least 2-lines (10 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery.\n7. Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes.\n8. Have an ECD of at least 1600 cells per square mm in both eyes.\n9. Be willing to participate in a postoperative training program for the use of the SING IMT™ implant.\n10. Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed.\n11. Patient is registered with the national social security or equivalent in the country where consent is signed\n12. A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n13, Not a woman of childbearing potential (WOCBP): A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through to the end of the study\n\nExclusion Criteria:\n\nA. Bilateral Ocular Conditions (affecting both eyes):\n\n1. Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months.\n2. Diabetic retinopathy.\n3. Retinal vascular diseases.\n4. History of retinal detachment.\n5. Retinitis pigmentosa.\n6. Intraocular tumor.\n7. Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata.\n8. Patient predisposing to eye rubbing\n\n   B. Surgical Eye Conditions:\n9. Narrow angle (i.e., \\\u003C Schaffer grade 2).\n10. Axial length \\\u003C21 mm or \\>26 mm.\n11. Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis.\n12. Plate haptic shape IOL implanted.\n13. Vitrectomized eye.\n14. Zonular weakness, instability, presence of pseudoexfoliation.\n15. Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization.\n16. Any IOL already implanted in the sulcus.\n17. Presence of toric or multifocal IOL types.\n18. Optic Nerve Disease\n\n    C. Systemic or Other General Conditions:\n19. A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP \\>22 mmHg.\n20. Known sensitivity to post-operative medications.\n21. Significant communication impairment or severe neurological disorders.\n22. Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study.\n23. Any condition or situation that, in the opinion of the investigator, may:\n\n    * Put the subject at significant risk,\n    * Confound the clinical investigation results, or\n    * Interfere significantly with the subject's participation in the study.\n24. Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.","ALL","55 Years",{"count":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Age - Related Macular Degeneration (AMD)",[29,30,31,32,33,34,35,36,37,38],"Sulcus","AMD","Age-related Macular Degeneration","IOL","Intra-Ocular Lens","Pseudophakic","Samsara Vision","Add-on","SINGIMT","lens-exchange","RECRUITING","2026-03-17",{"date":42,"type":43},"2026-03-20","ACTUAL",{"date":45,"type":43},"2025-09-23",{"date":47,"type":21},"2027-04-30",{"name":49,"class":50},"VisionCare, Inc.","INDUSTRY",12,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100423643","post-market-clinical-investigation-of-the-sing-imt-system-model-ng-si-imt-3x-in-patients-with-end-stage-age-related-macular-degeneration-100423643","NCT04796545","Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration","A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Be 55 years of age or older.\n2. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.\n3. Have evidence of cataract.\n4. Have best-corrected distance visual acuity (BCDVA) no better than 20\u002F80 (0.6 LogMAR) and no worse than 20\u002F800 (1.6 LogMAR) in both eyes.\n5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.\n6. 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).\n7. Have an ACD of at least 2.5 mm in the eye scheduled for surgery.\n8. Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.\n9. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.\n10. Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.\n2. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.\n3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\\>22 mm Hg.\n4. Corneal guttata.\n5. Known sensitivity to post-operative medications.\n6. Significant communication impairment or severe neurological disorders.\n7. 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.\n8. An ocular condition that predisposes the patient to eye rubbing.\n9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.\n10. Patients for whom the planned operative eye has:\n\n    * Myopia \\> 6.0 D\n    * Hyperopia \\> 4.0 D\n    * Axial length \\\u003C 21 mm\n    * Endothelial cell density \\\u003C 1600 cells per square mm\n    * Narrow angle, i.e., \\\u003C Schaffer grade 2.\n11. Inflammatory ocular disease.\n12. Cornea stromal or endothelial dystrophies, including guttata.\n13. Zonular weakness\u002Finstability of crystalline lens, or pseudoexfoliation.\n14. Diabetic retinopathy.\n15. Untreated retinal tears.\n16. Retinal vascular disease.\n17. Optic nerve disease.\n18. A history of retinal detachment.\n19. Retinitis pigmentosa.\n20. Intraocular tumor.\n21. 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.\n22. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.\n23. 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.",{"count":60,"type":21},76,[24],"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).\n\nEligible 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.",[30,64],"Age-Related Macular Degeneration",[66,67,68,69,70],"Age Related Macular Degeneration","Dry AMD","End-stage age-related macular degeneration","Central vision impairment","Geographic atrophy","2026-02-05",{"date":73,"type":43},"2026-02-10",{"date":75,"type":43},"2022-09-13",{"date":77,"type":21},"2028-12",{"name":49,"class":50},13,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100472964","multicenter-clinical-study-of-the-sing-imt-in-patients-with-late-stage-amd-100472964","NCT05438732","Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD","A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)","CONCERTO","Inclusion Criteria:\n\n1. Be at least 65 years of age at the Pre-operative Visit;\n2. Have ETDRS BCDVA 0.9 to 1.6 logMAR (20\u002F160 to 20\u002F800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;\n3. Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;\n4. Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:\n\n   1. lack of need of treatment for CNV over the past 6 months, and\n   2. lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and\n   3. lack of Retinal hemorrhage on exam over a 6-month period or longer\n5. Agree to participate in post-operative visual training\n\n   For the Implanted Eye:\n6. Have evidence of visually significant cataract at the Pre-operative Visit;\n7. Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment\n\n   For the Non-Implanted Eye:\n8. Have adequate peripheral vision at the Pre-operative Visit to allow navigation\n\nExclusion Criteria:\n\n1. Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training\u002Frehabilitation with the device;\n2. Have any of the following conditions at the Pre-operative Visit:\n\n   1. Stargardt macular dystrophy;\n   2. Diabetic retinopathy;\n   3. Untreated retinal tears;\n   4. Retinal vascular disease;\n   5. Optic nerve disease;\n   6. History of retinal detachment;\n   7. Intraocular tumor;\n   8. Retinitis pigmentosa;\n3. History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP \\>22 mmHg at the Pre-operative Visit;\n4. Have known allergy to post-operative medications;\n5. History of eye rubbing or an ocular condition that predisposes subject to eye rubbing;\n6. Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit;\n7. Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety;\n8. Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study;\n9. Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit\n\n   For the Implanted Eye:\n10. Have central anterior chamber depth (ACD) \\\u003C3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit;\n11. Have an Endothelial Cell Density (ECD) below:\n\n    1. 2,000 cells per millimeter, if 65-84 years old;\n    2. 1,800 cells per millimeter, if 85 years old or greater (based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit)\n12. Have a history of corneal stromal or endothelial dystrophies, including guttata;\n13. Have Myopia \\> 6.0 D or Hyperopia \\> 4.0 D by Manifest Refraction at the Pre-operative Visit;\n14. Have an Axial Length (AL) \\\u003C 21 mm at the Pre-operative Visit;\n15. Have a narrow angle defined as \\\u003C grade 2 on the Schaffer scale at the Pre-operative Visit;\n16. Ongoing Inflammatory ocular disease at the Pre-operative Visit;\n17. Zonular weakness\u002Finstability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit;\n18. Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery;\n19. Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes;\n\n    For the Non-Implanted Eye:\n20. Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.","65 Years",{"count":90,"type":21},125,[24],"The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).",[64,94],"Geographic Atrophy",[96,97],"cataract","best-corrected distance visual acuity","2024-11-27",{"date":100,"type":43},"2024-12-03",{"date":102,"type":43},"2022-06-16",{"date":104,"type":21},"2025-12",{"name":49,"class":50},10,""]