CXL: Assessment of Corneal Endothelium After Collagen Cross Linking

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04160338
Collaborator
(none)
25
27

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. endothelial cell count by specular microscopy. [from preoperatively to 6 months postoperatively]

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

Secondary Outcome Measures

  1. endothelial cell morphology by specular microscopy. [from preoperatively to 6 months postoperatively]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. patients with mild to moderate corneal ectasia who are candidates for CXL.
Exclusion Criteria:
  1. patients with advanced corneal ectasia with maximum keratometry readings <56 diopters.

  2. corneal pachymetry >380um.

  3. corneal scarring.

  4. previous corneal surgeries (e.g intrastromal corneal ring segments)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Mohamed T Abdelmonem, Professor, Assiut Uneversity
  • Study Director: Hazem A Hazem, lecturer, Assiut Uneversity
  • Study Director: Mahmoud A Abdelsalam, lecturer, Assiut Uneversity

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Naglaa Mostafa Abdelhafez Abdelmohsen, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT04160338
Other Study ID Numbers:
  • corneal collagen cross linking
First Posted:
Nov 13, 2019
Last Update Posted:
Nov 13, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 13, 2019