Participants with refractive error who are LASIK candidates at Chiang Mai University LASIK center inflammation laser refractive surgery cornea
Conditions
Interventions
Experimental Drug,No Intervention No treatment
Sponsors
Thailand Science Research and Innovation (TSRI)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
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 1, day 7, month 1, month 3 and month 6) Clinical evaluation,Corneal staining At screening day, surgery day (before surgery) and after surgery (day 1, day 7, 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 densitometry values, thickness of central white opacity from anterior segment ocular coherence tomography,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
Public ContactPhit Upaphong
Faculty of Medicine, Chiang Mai University
Outcome results
None listed