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Assessment of Corneal Endothelium After Collagen Cross Linking

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04160338
Acronym
CXL
Enrollment
25
Registered
2019-11-13
Start date
2019-12-31
Completion date
2022-03-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accelerated Corneal Collagen Cross Linking

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.

Interventions

An informed written consent will be obtained from all patients that will be included in this study. Patients in this study will undergo specular microscopic examination of corneal endothelium before CXL procedure. Patients will be assigned to undergo accelerated (epithelium-off ,transepithelial ) CXL . Follow up specular microscopy will be done 3 months and 6 months after corneal collagen cross linking procedure .

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
endothelial cell count by specular microscopy.from preoperatively to 6 months postoperativelyspecular microscopy will be used to assess corneal endothelial cell count after accelerated corneal collagen cross linking

Secondary

MeasureTime frameDescription
endothelial cell morphology by specular microscopy.from preoperatively to 6 months postoperativelyspecular microscopy will be used to assess corneal endothelial cell morphology after accelerated corneal collagen cross linking

Contacts

Primary ContactNaglaa MA Abdelmohsen, M.B.B.CH.
dr.naglaa15@gmail.com+201095459579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026