Participants with corneal ectasia who are CXL candidate at Chiang Mai University hospital antioxidants corneal collagen cross-linking
Conditions
Interventions
Topical pirenoxine 4 times daily (one time immediately after surgery, and continued to 6 months after surgery) plus regular medications,Regular medications including the antibiotic eye drops (0.5% le
Experimental Drug,No Intervention No treatment
Pirenoxine,Regular medication alone
Sponsors
Thailand Science Research and Innovation (TSRI)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age equals or more than 18 years old 2) Primary keratoconus with documented progression by serial topography progression: - an increase in maximum keratometry (Kmax) of more than 1 diopter (D) over 1 year or - a decrease in the thinnest pachymetry by more than 5% over 1 year or - a history of an increase in manifest cylinder of more than 1 D or an increase in spherical equivalence of more than 0.5 D over a period of 1 year 3) Best corrected visual acuity (BCVA) less than 20/20 or 6/6
Exclusion criteria
Exclusion criteria: 1) Corneal thickness < 400 micron 2) Active corneal infections or active uveitis or history of herpes keratitis 3) Ocular, corneal, or immune system disorders including corneal scar/opacity 4) Administration of oral antioxidant/vitamin supplements within 1 month 5) Using topical steroids/NSAIDs/pirenoxine within 1 month 6) Using soft contact lens within 2 weeks or RGP contact lens within 1 month 7) History of allergy to pirenoxine or their ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxidative damage At surgery day and after surgery (day 1, day 7, month 1, month 3 and month 6) 8-isoprostane (IsoP) in tear fluid,Inflammation At surgery day 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 surgery day 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,Apoptosis At surgery day 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 surgery day 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
| Measure | Time frame |
|---|---|
| Biomechanical parameters At surgery day and after surgery ( month 1, month 3 and month 6) Biomechanical parameters,Tear breakup time At surgery day and after surgery ( day 7, month 1, month 3 and month 6) Clinical evaluation,Corneal staining At surgery day and after surgery ( day 7, month 1, month 3 and month 6) Corneal staining grading score,Conjunctival hyperemia At surgery day and after surgery ( day 1, day 7, month 1, month 3 and month 6) Conjunctival hyperemia grading score,Corneal opacity At surgery day and after surgery ( month 1, month 3 and month 6) Corneal opacity,Visual acuity At surgery day and after surgery ( day 7, month 1, month 3 and month 6) EDTRS visual acuity | — |
Countries
Thailand
Contacts
Public ContactPhit Upaphong
Faculty of Medicine, Chiang Mai University
Outcome results
None listed