Search / Trial NCT06235567

Dextenza for Corneal Crosslinking

Launched by MAANASA INDARAM, MD · Jan 23, 2024

Trial Information

Current as of December 22, 2024

Enrolling by invitation

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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
  • Exclusion Criteria:
  • 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

Trial Officials

Maanasa Indaram, MD

Principal Investigator

University of California, San Francisco

About Maanasa Indaram, Md

Maanasa Indaram, MD, is a dedicated clinical trial sponsor specializing in innovative research and development within the healthcare sector. With a strong focus on advancing therapeutic options and improving patient outcomes, Dr. Indaram leads a team committed to rigorous scientific methodologies and ethical practices in clinical trials. Her expertise encompasses a range of medical specialties, enabling the exploration of groundbreaking treatments. Through collaboration with research institutions and healthcare professionals, Dr. Indaram aims to contribute to the body of medical knowledge and enhance the quality of care for diverse patient populations.

Locations

San Francisco, California, United States

San Francisco, California, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0