Summary

Eligibility
for people ages 13-64 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Maanasa Indaram, MD
Headshot of Maanasa Indaram
Maanasa Indaram

Description

Summary

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.

Official Title

Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking

Keywords

Keratoconus, Dexamethasone, Dexamethasone acetate, BB 1101, Dextenza 0.4Mg Ophthalmic Insert, Dextenza insert

Eligibility

You can join if…

Open to people ages 13-64

  • The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
    1. Progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction
    2. Patients requiring general anesthetic for the procedure
    3. Preoperative central corneal thickness of >= 400 microns

You CAN'T join if...

  • History of acute hydrops in treated eye
  • History of pre-existing severe corneal scarring in the treated eye
  • History of pre-existing glaucoma in the treated eye
  • History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
  • History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
  • Active infectious systemic disease
  • Obstructed nasolacrimal duct in the study eye(s)
  • Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm.
  • Patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region
  • Hypersensitivity to dexamethasone
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Locations

  • UCSF Pediatric Ophthalmology
    San Francisco California 94158 United States
  • Mission Bay Hospital
    San Francisco California 94158 United States
  • Wayne and Gladys Center for Vision
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Maanasa Indaram, MD
    Dr. Maanasa Indaram is an ophthalmologist who cares for children with all types of eye conditions, as well as adults with strabismus (abnormal eye alignment), eye movement disorders and keratoconus (a vision-affecting disorder of the cornea).

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Maanasa Indaram, MD
ID
NCT06235567
Phase
Phase 1/2 Keratoconus Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated