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

Completed · Phase 4

Conditions studied: Keratoconus, Unstable, Collagen Crosslinking, Postoperative Pain

In brief

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.

Key facts

Study ID

NCT04168112

Run by

Sight Medical Doctors PLLC

People needed

20

Starts

2020-02-12

Expected to finish

2023-04-05

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SightMD — Babylon, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.