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

Sight Medical Doctors PLLC

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Collagen Crosslinking; Keratoconus, Unstable

Treatments: Drug: Dextenza; Drug: Prednisolone Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04168112

LINK1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A

Experimental group

Description:

Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days).

Treatment:

Drug: Dextenza

Group B

Active Comparator group

Description:

Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week.

Treatment:

Drug: Prednisolone Acetate