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NCT07911930
LacriFill Canalicular Occlusion for Dry Eye After LASIK
Conditions: Dry Eye Syndrome
Sex: All
Ages: 18 Years – 39 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Mann Eye Institute
Location: Mann Eye Institute Houston Texas
Summary
This study is a single-site, prospective, randomized (2:1) controlled study of subjects aged 18-39 who are candidates for bilateral LASIK and have dry eye symptoms (OSDI ≥13). The LacriFill group (n=50) receives bilateral lower canalicular LacriFill placement within 7 days prior to surgery plus standard postoperative care; the control group (n=25) receives standard postoperative care only. The primary outcome is the change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months after bilateral LASIK.
Eligibility Criteria
Inclusion Criteria:
Age 18-39 years. Bilateral LASIK candidate. OSDI ≥13. BCDVA 20/20 or better. Discontinue soft contact lenses within 5 days of surgery and RGP lenses 4 weeks prior.
Able to complete study visits.
Exclusion Criteria:
Previous ocular surgery. Keratoconus or ectasia. Autoimmune disease. Pregnancy. Uncontrolled diabetes. Significant ocular surface disease unrelated to LASIK. Active ocular infection or inflammation.
The 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.
Source: ClinicalTrials.gov (NCT07911930). StuddyBuddy aggregates publicly available trial information.