Effects of Topical Pirenoxine on Oxidative Damage and Inflammation of Cornea After PRK: a randomized controlled trial

INTERVENTION: Experimental Drug,Placebo Comparator Drug Pirenoxine,Hydroxypropyl methylcellulose Topical pirenoxine 4 times daily (14 days before surgery, and continued to 6 months after surgery),Topical hydroxypropyl methylcellulose based artificial tears 4 times daily (14 days before surgery, and continued to 6 months after surgery) CONDITION: antioxidants ; laser refractive surgery ; cornea Participants with refractive error who are PRK candidates at Chiang Mai University LASIK center ; antioxidants ; laser refractive surgery ; cornea PRIMARY OUTCOME: Oxidative damage At screening day, surgery day (before and after surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) 8‐isoprostane (IsoP) in tear fluid,Inflammation At screening day, surgery day (before and after surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) tumor necrosis factor‐alpha and interleukin‐6 in tear fluid,Wound healing At screening day, surgery day (before and after surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) matrix metalloproteinase‐9 (MMP‐9), Tissue inhibitor of metalloproteinase‐1 (TIMP1) in tear fluid,Corneal nerve healing substance P, nerve growth factor (NGF) in tear fluid substance P, nerve growth factor (NGF) in tear fluid,Apoptosis At screening day, surgery day (before and after surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) Caspase‐3, B‐cell lymphoma protein 2 (Bcl‐2), Bcl‐2‐associated X protein (BAX) in tear fluid,Pyroptosis At screening day, surgery day (before and after surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) Gasdermin D (GSDMD), Cleaved GSDMD, NLR family pyrin domain containing 3 (NLP3) in tear fluid SECONDARY OUTCOME: Biomechanical parameters At screening day, surgery day (before surgery) and after surgery (month 3 and month 6) CorvisST A1 velocity, DA ratio 2 mm, integrated radius, SP‐A1,Tear breakup time At screening day, surgery day (before surgery) and after surgery (day 7, month 1, month 3 and month 6) Clinical evaluation,Corneal staining At screening day, surgery day (before surgery) and after surgery month 1, month 3 and month 6) Corneal staining grading score,Conjunctival hyperemia At screening day, surgery day (before surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) Conjunctival hyperemia grading score,Corneal opacity At screening day, surgery day (before surgery) and after surgery (month 1, month 3 and month 6) Corneal opacity,Corneal nerve density At screening day and 6 months after surgery Central corneal nerve density from confocal microscopy,Visual acuity At screening day, surgery day (before surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) EDTRS visual acuity INCLUSION CRITERIA: The difference of refractive error between eyes less than 1 diopter of spherical equivalence