Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 11, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Keratoconus
Interventions
DRUG

Dextenza 0.4Mg Ophthalmic Insert

This insert allows for sustained release of dexamethasone onto the ocular surface over a period of 28 days. It requires a single application and eliminates the potential for noncompliance, difficulty in administration and poor accuracy. Dextenza has been FDA approved for post-operative pain and inflammation following ophthalmic surgery. The pivotal trials included patients undergoing cataract surgery, not CXL surgery. In addition, the age range did not include those of pediatric age.

DRUG

topical prednisolone acetate 1% (PredForte) eye drops

The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.

Trial Locations (3)

94158

Mission Bay Hospital, San Francisco

UCSF Pediatric Ophthalmology, San Francisco

Wayne and Gladys Center for Vision, San Francisco

All Listed Sponsors
lead

Maanasa Indaram, MD

OTHER