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.

Keratoconus is a progressive ectatic disease of the cornea, leading to worsening of astigmatism and vision over time. With FDA approval of corneal collagen cross-linking (CXL), we now have the ability to halt the progression of keratoconus and prevent further vision loss in these patients. Although CXL has now become standard of care, the immediate post-operative period can be quite painful despite use of anti-inflammatory medications/eye drops. The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye drop therapy.

To date, no studies have been performed evaluating the success of an intracanalicular dexamethasone insert for the treatment of postoperative inflammation and pain in corneal cross-linking patients. Oftentimes, patients experience a great deal of discomfort post-CXL, which may also make it difficult to apply eye drops in the correct fashion. Use of a dexamethasone insert alleviates the need for postoperative steroid eye drops and may provide increased pain relief post-CXL as compared to topical therapy. This will be a head-to-head study where steroid therapy (topical or insert) will begin in a standard fashion on the date of CXL. This will allow for accurate comparison of a 4-week taper of topical steroids, versus a dexamethasone insert designed to release steroid for 30 days.

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

We do not plan to share individual participant data (IPD) with other researchers. However, any adverse events will be reported to the governing institutional review board (IRB) and Ocular Therapeutix and FDA if applicable.

Primary endpoints: postoperative pain between groups and degree of ocular surface inflammation.

Secondary endpoints: rate of corneal re-epithelialization, change in intraocular pressure (mm Hg), use of rescue medications, changes in corrected distance visual acuity and central corneal pachymetry. Demographics such as age and sex were correlated with results. Notation was made of any incidence and severity of adverse events during the study.

Adverse event data were collected from baseline through the end of the study period (~1 month)

The definition of adverse event/serious adverse event does not differ from clinicaltrials.gov Definitions.

The biggest limitation of this study is the small sample size; 20 eyes in each group limit findings of statistical significance; larger future studies may help more definitively illuminate differences between groups. We also had 2 patients in the control group who dropped out of the study early on-data from their experiences would have been valuable in terms of comparisons between groups.