Assessment of Corneal Endothelium After Collagen Cross Linking (CXL)

November 8, 2019 updated by: Naglaa Mostafa Abdelhafez Abdelmohsen, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent accelerated corneal collagen cross linking

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from preoperatively to 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial cell morphology by specular microscopy.
Time Frame: from preoperatively to 6 months postoperatively
specular microscopy will be used to assess corneal endothelial cell morphology after accelerated corneal collagen cross linking
from preoperatively to 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • corneal collagen cross linking

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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