NCT04160338|Unknown
Assessment of Corneal Endothelium After Collagen Cross Linking
CXL
A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
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CXL
A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
Sponsor study identifier
observational
25
0 countries
N/A
Study Start
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2019
Actual (reported)November 13, 2019
Actual (reported)December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
endothelial cell count by specular microscopy.
specular microscopy will be used to assess corneal endothelial cell count after accelerated corneal collagen cross linking
from preoperatively to 6 months postoperatively
endothelial cell morphology by specular microscopy.
from preoperatively to 6 months postoperatively
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 .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients who underwent accelerated corneal collagen cross linking
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.
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.
Mohamed T Abdelmonem, Professor
Assiut Uneversity
Hazem A Hazem, lecturer
Assiut Uneversity
Mahmoud A Abdelsalam, lecturer
Assiut Uneversity
First Submitted
November 8, 2019
First Posted
November 13, 2019
Study Start
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2021
Effect of Epi-Off Technique Corneal CXL On Endothelial Count by Specular Microscopy in Keratoconus Patients
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Abdel-Radi M, Abdelmohsen N, Abdelmotaal H, Abd El-Moneim MT. The effect of accelerated pulsed high-fluence corneal cross-linking on corneal endothelium; a prospective specular microscopy study. BMC Ophthalmol. 2023 Apr 18;23(1):163. doi: 10.1186/s12886-023-02912-6.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 13, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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