Participants with refractive error who are PRK candidates at Chiang Mai University LASIK center inflammation laser refractive surgery cornea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The difference of refractive error between eyes less than 1 diopter of spherical equivalence
Exclusion criteria
Exclusion criteria: 1) Any contraindications for laser refractive surgery including active ocular/ systemic diseases, corneal anatomy pathology, significant cataract, abnormal corneal topography/tomography, significant corneal thinning, unstable refractive error, having keloid or hypertrophic scar, and pregnant/ lactation 2) Presence of corneal scar or corneal opacity 3) Significant dry eye symptom in which ocular surface disease index (OSDI) > 18 4) Administration of oral antioxidant/vitamin supplements within 1 month 5) Using topical steroids/NSAIDs/pirenoxine within 1 month 6) Duration between screening visit and surgery less than 2 weeks 7) Using soft contact lens within 2 weeks 8) History of allergy to pirenoxine, artificial tears or their ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear secretion At screening day, surgery day (before surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) Schirmer I test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 healing At screening day, surgery day (before surgery) and after surgery (day 1, day 7, month 1, month 3 and month 6) nerve growth factor (NGF) 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) IL1, IL6, IL8, TNF, MCP-1 | — |
Countries
Thailand
Contacts
Faculty of Medicine, Chiang Mai University