Assessment of Corneal Endothelium After Collagen Cross Linking

NCT04160338 | Unknown

• 1 other identifier: corneal collagen cross linking
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Conditions

Accelerated Corneal Collagen Cross Linking

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• endothelial cell morphology by specular microscopy.

  from preoperatively to 6 months postoperatively

Interventions

specular microscopy DEVICE

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 .

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent accelerated corneal collagen cross linking

You may qualify if:

• \. patients with mild to moderate corneal ectasia who are candidates for CXL.

You may not qualify if:

• patients with advanced corneal ectasia with maximum keratometry readings \<56 diopters.
• corneal pachymetry \>380um.
• corneal scarring.
• previous corneal surgeries (e.g intrastromal corneal ring segments)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 18471635 BACKGROUND

• 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.

  PMID: 29623463 BACKGROUND

• 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.

  PMID: 20447101 BACKGROUND

• 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.

  PMID: 30073363 BACKGROUND

• 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.

  PMID: 31172016 BACKGROUND

• 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.

  PMID: 29621306 BACKGROUND

• 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.

  PMID: 23521904 BACKGROUND

• 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.

  PMID: 25949080 BACKGROUND

• 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.

  PMID: 37072730 DERIVED

Study Officials

• Mohamed T Abdelmonem, Professor

  Assiut Uneversity

  STUDY DIRECTOR

• Hazem A Hazem, lecturer

  Assiut Uneversity

  STUDY DIRECTOR

• Mahmoud A Abdelsalam, lecturer

  Assiut Uneversity

  STUDY DIRECTOR

Central Study Contacts

Naglaa MA Abdelmohsen, M.B.B.CH.

CONTACT

+201095459579; dr.naglaa15@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: December 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: November 13, 2019

Record last verified: 2019-11