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Search / Trial NCT06267495

Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus

Launched by ASSIUT UNIVERSITY · Feb 19, 2024

Trial Information

Current as of August 11, 2025

Completed

Keywords

Keratoconus Corneal Cross Linking Epithelium On Cxl

ClinConnect Summary

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.

Although several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:
  • 1. Normal slit lamp examination
  • 2. Normal topography in FFKC and suspicious topography in subclinical KC with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 D in the anterior sagittal curvature map in pentacam)
  • 3. Clinical and topographic features of KC in the other eye.
  • Exclusion Criteria:
  • 1. Corrected distance visual acuity (CDVA) worse than 0.1 logMAR
  • 2. Corneal thickness at the thinnest location less than 400 μm
  • 3. Severe ocular allergy (active catarrhal keratoconjunctivitis)
  • 4. Other corneal or ocular diseases
  • 5. Systemic diseases such as diabetes mellitus and autoimmune diseases

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, , Egypt

Patients applied

0 patients applied

Trial Officials

Mahmoud Abdel-Radi, MD

Principal Investigator

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported