Clinical trial NCT04160338: Assessment of Corneal Endothelium After Collagen Cross Linking
Official title: A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Accelerated Corneal Collagen Cross Linking
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent 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.

Eligibility criteria: 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)

Primary outcomes:
measure: endothelial cell count by specular microscopy.
timeFrame: from preoperatively to 6 months postoperatively
Secondary outcomes:
measure: endothelial cell morphology by specular microscopy.
timeFrame: from preoperatively to 6 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Assiut Uneversity
name: Mohamed T Abdelmonem, Professor
role: STUDY_DIRECTOR
affiliation: Assiut Uneversity
name: Hazem A Hazem, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut Uneversity
name: Mahmoud A Abdelsalam, lecturer
role: STUDY_DIRECTOR
References:
citation: Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
citation: Subasinghe SK, Ogbuehi KC, Dias GJ. Current perspectives on corneal collagen crosslinking (CXL). Graefes Arch Clin Exp Ophthalmol. 2018 Aug;256(8):1363-1384. doi: 10.1007/s00417-018-3966-0. Epub 2018 Apr 6.
citation: Mencucci R, Marini M, Paladini I, Sarchielli E, Sgambati E, Menchini U, Vannelli GB. Effects of riboflavin/UVA corneal cross-linking on keratocytes and collagen fibres in human cornea. Clin Exp Ophthalmol. 2010 Jan;38(1):49-56. doi: 10.1111/j.1442-9071.2010.02207.x.
citation: Wen D, Li Q, Song B, Tu R, Wang Q, O'Brart DPS, McAlinden C, Huang J. Comparison of Standard Versus Accelerated Corneal Collagen Cross-Linking for Keratoconus: A Meta-Analysis. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):3920-3931. doi: 10.1167/iovs.18-24656.
citation: Kirgiz A, Eliacik M, Yildirim Y. Different accelerated corneal collagen cross-linking treatment modalities in progressive keratoconus. Eye Vis (Lond). 2019 Jun 3;6:16. doi: 10.1186/s40662-019-0141-6. eCollection 2019.
citation: Zhang X, Zhao J, Li M, Tian M, Shen Y, Zhou X. Conventional and transepithelial corneal cross-linking for patients with keratoconus. PLoS One. 2018 Apr 5;13(4):e0195105. doi: 10.1371/journal.pone.0195105. eCollection 2018.
citation: Vazirani J, Bagga B, Taneja M. Persistent corneal edema after collagen cross-linking for keratoconus. Am J Ophthalmol. 2013 Apr;155(4):775. doi: 10.1016/j.ajo.2013.01.003. No abstract available.
citation: Sedaghat M, Bagheri M, Ghavami S, Bamdad S. Changes in corneal topography and biomechanical properties after collagen cross linking for keratoconus: 1-year results. Middle East Afr J Ophthalmol. 2015 Apr-Jun;22(2):212-9. doi: 10.4103/0974-9233.151877.