Skip to main content
Clinical Trials/NCT04160338
NCT04160338
Unknown
Not Applicable

A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking

Assiut University0 sites25 target enrollmentDecember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accelerated Corneal Collagen Cross Linking
Sponsor
Assiut University
Enrollment
25
Primary Endpoint
endothelial cell count by specular microscopy.
Last Updated
6 years ago

Overview

Brief Summary

The aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy

Detailed Description

Keratoconus (KC) is a progressive, non-inflammatory corneal degenerative disease. It is a pathology characterized by a progressive thinning and protrusion of the cornea that ends in a cone-shaped cornea. This results in progressive myopia and irregular astigmatism with associated progressive loss of vision and thus reduced quality of life.Collagen cross-linking (CXL) is a relatively new conservative approach for progressive corneal ectasia. The main indication for CXL is to slow the progression of corneal ectatic diseases, such as keratoconus, pellucid marginal degeneration (PMD), keratoglobus and iatrogenic ectasia.The basic principle of this method is the chemical interaction of ultraviolet A radiation (315-400nm ) and riboflavin to induce covalent bond formation between collagen fibers of the cornea. In this way, the stiffness and rigidity of the cornea are provided.Corneal collagen cross-linking (CXL) was first introduced by Wollensak with an ultraviolet-A (UVA) protocol of 3 medium wave mW/cm2 intensity at 370 nm over an exposure time of 30 minutes (now termed the "Dresden protocol"). Researchers have proposed accelerated CXL (ACXL) protocols, to improve convenience and comfort for patients. These ACXL protocols have the aim of decreasing UVA exposure time by increasing UVA fluency to achieve the same overall total UVA dosage.Despite corneal CXL is a safe and effective procedure with few known side effects .Persistent corneal edema and possible endothelial cell damage have been reported in a few cases after CXL. Based on the extent of endothelial damage, patients may require penetrating keratoplasty.

Registry
clinicaltrials.gov
Start Date
December 2019
End Date
March 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naglaa Mostafa Abdelhafez Abdelmohsen

resident doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients with mild to moderate corneal ectasia who are candidates for CXL.

Exclusion Criteria

  • patients with advanced corneal ectasia with maximum keratometry readings \<56 diopters.
  • corneal pachymetry \>380um.
  • corneal scarring.
  • previous corneal surgeries (e.g intrastromal corneal ring segments)

Outcomes

Primary Outcomes

endothelial cell count by specular microscopy.

Time Frame: from preoperatively to 6 months postoperatively

specular microscopy will be used to assess corneal endothelial cell count after accelerated corneal collagen cross linking

Secondary Outcomes

  • endothelial cell morphology by specular microscopy.(from preoperatively to 6 months postoperatively)

Similar Trials