Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
Condition: Keratoconus, Unstable; Collagen Crosslinking; Postoperative Pain
MeSH terms: Keratoconus; Inflammation
Intervention: Dextenza; Prednisolone Acetate
Intervention description: Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain; post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two cohorts of patients will be studied (10 patients each group). Cohort A: intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or another class if allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily x 10 days).
Cohort B: Patients are placed on standard postoperative regimen of postoperative fluoroquinolone antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily (QID) x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: 4 times daily x1 week, three times daily (TID) x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week).
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Collagen Crosslinking; Keratoconus; Dexamethasone; Intracanalicular Insert

Summary:

      There is no standard of care medication regimen for the management of pain and inflammation
      post-corneal crosslinking (CXL), although most cornea specialists agree on use of an
      antibiotic and steroid eye drop in the immediate postoperative period. However, steroid
      tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID)
      eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain
      scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL,
      versus those receiving an intracanalicular dexamethasone insert.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Progressive keratoconus with planned corneal cross-linking in one or both eyes

          -  Age 18 years and older

          -  Ability to provide informed consent for procedures

          -  Ability to attend scheduled follow up visits

        Exclusion Criteria:

          -  Age less than 18

          -  Pregnancy/currently breast-feeding

          -  Inability to provide informed consent

          -  Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)

          -  Punctal stenosis

          -  Previous corneal transplant surgery

          -  Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)

          -  Concurrent use of topical steroid eye drops

          -  Systemic, topical or intravitreal steroid use within 1 month of baseline

          -  Active history of chronic or recurrent inflammatory eye disease in either eye

          -  History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella
             Zoster, Epstein Barr, Cytomegalovirus)

          -  History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities
             that may preclude proper healing