[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07648095":3,"trial-entities:NCT07648095":88,"trial-summary:NCT07648095":92},{"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":36,"sex":48,"minimum_age":49,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":60,"locations":63,"central_contacts":81,"overall_officials":83,"references":86,"see_also_links":87},"NCT07648095","ND-26-01","Lacrifill for Ocular Surface Optimization in Cataract Surgery","Evaluation of Lacrifill™ Canalicular Filler for Optimization of Ocular Surface Parameters and Biometric Precision in Prospective Cataract Surgery Patients With Dry Eye Disease","NOT_YET_RECRUITING","2027-07-15","2026-06","2026-06-15","2026-07-15","The Eye Institute of West Florida","OTHER",false,"This is a single-site observational study designed to evaluate the efficacy of Lacrifill™ canalicular filler in optimizing ocular surface parameters and biometric precision in prospective cataract surgery patients with dry eye disease (DED).",null,[19],"Cataract",[],"OBSERVATIONAL",[],{"count":24,"type":25},65,"ESTIMATED",[27],{"type":28,"name":29,"description":29,"armGroupLabels":30},"DEVICE","Lacrifill Canalicular Filler",[29],[32],{"measure":33,"description":34,"timeFrame":35},"Mean absolute error (MAE)","Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry.","1 month postoperatively",[37,39,43,45],{"measure":38,"timeFrame":35},"Difference in mean magnitude of postoperative refractive astigmatism",{"measure":40,"description":41,"timeFrame":42},"Lens type candidacy","Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement.","Preoperative assessment",{"measure":44,"timeFrame":35},"Postoperative uncorrected visual acuity (logMAR)",{"measure":46,"description":47,"timeFrame":35},"Subjective visual satisfaction","National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). Graded on a scale from 1 to 5 with lower scores indicative of higher satisfaction.","ALL","40 Years",{"inclusion":51,"exclusion":56,"raw_text":59},[52,53,54,55],"Age \\>= 40 years","Diagnosed dry eye (OSDI \\>= 13, TBUT \\\u003C 10 sec, or Oxford staining \\>= Grade 2)","No recent ocular surgeries (\\\u003C6 months)","No significant changes in DED regimen within last 1 month",[57,58],"Previous punctal plugs or canalicular cautery","Active ocular inflammation or corneal pathology unrelated to DED","Inclusion Criteria:\n\n* Age \\>= 40 years\n* Diagnosed dry eye (OSDI \\>= 13, TBUT \\\u003C 10 sec, or Oxford staining \\>= Grade 2)\n* No recent ocular surgeries (\\\u003C6 months)\n* No significant changes in DED regimen within last 1 month\n\nExclusion Criteria:\n\n* Previous punctal plugs or canalicular cautery\n* Active ocular inflammation or corneal pathology unrelated to DED",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":13,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":78},"Largo","Florida","33770","United States",[70,75],{"name":71,"role":72,"phone":73,"email":74},"Renee Bondurant","CONTACT","727-450-4668","Renee.Bondurant@eyespecialist.com",{"name":76,"role":77},"Neel R Desai, MD","PRINCIPAL_INVESTIGATOR",{"lat":79,"lon":80},27.90979,-82.78842,[82],{"name":71,"role":72,"phone":73,"email":74},[84],{"name":85,"affiliation":13,"role":77},"Neel Desai, MD",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[19,90],"Dry Eye Syndrome",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]