[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06555289":3,"trial-entities:NCT06555289":96,"trial-summary:NCT06555289":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":35,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":17,"eligibility_criteria":48,"std_ages":69,"locations":72,"central_contacts":90,"overall_officials":92,"references":94,"see_also_links":95},"NCT06555289","RM-24-01","Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery","Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery","RECRUITING","2026-09-01","2025-12","2025-12-12","2024-10-23","Juliette Eye Institute Research Center","OTHER",false,"This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.",null,[19],"Cataract",[],"OBSERVATIONAL",[],{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"DEVICE","Clareon PanOptix Pro IOL","Spherical and toric T3",[32],{"measure":33,"timeFrame":34},"Binocular corrected distance visual acuity (logMAR)","3 months postoperative",[36,38,40,42,44],{"measure":37,"timeFrame":34},"Binocular distance corrected visual acuity at intermediate (logMAR)",{"measure":39,"timeFrame":34},"Binocular distance corrected visual acuity at near (logMAR)",{"measure":41,"timeFrame":34},"Binocular unccorrected visual acuity at distance (logMAR)",{"measure":43,"timeFrame":34},"Binocular unccorrected visual acuity at intermediate (logMAR)",{"measure":45,"timeFrame":34},"Binocular unccorrected visual acuity at near (logMAR)","ALL","45 Years",{"inclusion":49,"exclusion":55,"raw_text":68},[50,51,52,53,54],"Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.","Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.","Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.","Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3","Postoperative visual potential of monocular 20\u002F25 or better, in the surgeon's judgement.",[56,57,58,59,60,61,62,63,64,65,66,67],"Any ocular comorbidity that might hamper postoperative visual acuity:","Corneal abnormality including corneal dystrophy, irregularity, and degeneration.","Moderate or severe dry eyes that can't be relieved after treatment.","History of or current anterior and posterior inflammation of any etiology.","Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.","Glaucoma of any kind.","Pregnancy or lactation.","Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).","Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)","Apple Kappa\u002Fchord mu ≥ 0.6.","Higher order corneal aberrations at pupil diameter of 4mm: \\> 0.6 total RMS, \\> 0.3 coma, \\> 0.3 trefoil (to exclude irregular corneas)","Any patient requiring a limbal relaxing incision.","Inclusion Criteria:\n\n* Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.\n* Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.\n* Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.\n* Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3\n* Postoperative visual potential of monocular 20\u002F25 or better, in the surgeon's judgement.\n\nExclusion Criteria:\n\n* Any ocular comorbidity that might hamper postoperative visual acuity:\n\n  * Corneal abnormality including corneal dystrophy, irregularity, and degeneration.\n  * Moderate or severe dry eyes that can't be relieved after treatment.\n  * History of or current anterior and posterior inflammation of any etiology.\n  * Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.\n  * Glaucoma of any kind.\n  * Pregnancy or lactation.\n* Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).\n* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)\n* Apple Kappa\u002Fchord mu ≥ 0.6.\n* Higher order corneal aberrations at pupil diameter of 4mm: \\> 0.6 total RMS, \\> 0.3 coma, \\> 0.3 trefoil (to exclude irregular corneas)\n* Any patient requiring a limbal relaxing incision.\n\nThe principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":13,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Albuquerque","New Mexico","87113","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Zoe Baker, OD","CONTACT","505-355-2020","dr.baker@julietteeye.com",{"name":85,"role":86},"Robert Melendez, MD, MBA","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},35.08449,-106.65114,[91],{"name":80,"role":81,"phone":82,"email":83},[93],{"name":85,"affiliation":13,"role":86},[],[],{"nct_id":4,"conditions":97,"biomarkers":98},[19],[],{"nct_id":4,"found":100,"summary":101,"prompt_version":110},true,{"design":102,"status":103,"heading":6,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study with 40 participants, meaning researchers will observe outcomes without assigning different treatments. It is a single-center, single-arm study, so all participants will receive the same intervention.","completed","This study is looking at how well a specific type of lens, the Clareon PanOptix Pro IOL, works for people having cataract surgery who have previously had vision correction surgery like LASIK or PRK. You might be able to join if you are an adult aged 45 or older with cataracts in both eyes, have had prior myopic (nearsighted) refractive surgery, and have regular corneal astigmatism (a common vision problem) of 0.6 D or less. The study will measure success by checking your binocular (using both eyes) corrected distance visual acuity (how well you see with glasses or contacts) three months after surgery. The current recruitment status is unclear.","You will be followed for three months after your surgery to measure your visual acuity.",109,"You would have assessments before surgery, and then again at 1 and 3 months after surgery. These assessments include questionnaires, eye exams, and measurements of your vision.","Not stated in the trial record.",[29],"v2"]