CompletedPhase 4

Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study

United States20 participantsStarted 2020-02-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)

Timeframe: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)

Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)

Timeframe: assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)

Trial details

NCT IDNCT04168112

SponsorSight Medical Doctors PLLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-24

Results submitted2023-11-20

View on ClinicalTrials.gov More Keratoconus, Unstable trials