Evaluation of the Keratoconic Cornea After Corneal Collagen Cross Linking.

NCT03879421 | Unknown

• 1 other identifier: TROASOCTIEOTKCACCCL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of work:

• To detect abnormal corneal thinning in keratoconus using pachymetry maps measured by high-speed anterior segment optical coherence tomography (OCT).
• To evaluate the visualization and depth of the demarcation line with anterior segment optical coherence tomography (AS-OCT) after corneal collagen cross-linking (CXL).
• To compare the depth of demarcation line between epithelial-on (Epi-on) and epithelial-off (Epi-off) corneal collagen cross-linking.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (3)

• Demarcation line (DL) depth

  DL is a hyper-reflectivity seen in the anterior corneal stroma between the crossed and non-crossed collagen stromal bundles using anterior segment optical coherence tomography.

  3 months post corneal collagen cross linking

• Change in maximum keratometry (K-max) in diopters (D)

  to compare preoperative values of K-max with values at both 6 and 12 months follow up visits.

  preoperative, 6 months and 12 months postoperative

• Change in central corneal thickness in (µm)

  using anterior segment OCT

  preoperative, 6 months and 12 months postoperative

Secondary Outcomes (3)

• Change in visual acuity

  preoperative, 6 months and 12 months postoperative

• Change in the mean refractive spherical equivalent (MRSE)

  preoperative, 6 months and 12 months postoperative

• Change in pachymetry at the thinnest location

  preoperative, 6 months and 12 months postoperative

Study Arms (2)

Group 1 (Epithelium-off accelerated CXL)

ACTIVE COMPARATOR

patients with corneal thickness \> 400 µm (thinnest location) were assigned into Epi-off accelerated CXL procedure

Procedure: Accelerated corneal collagen cross linking

Group 2 (Epithelium-on accelerated CXL)

ACTIVE COMPARATOR

patients with corneal thickness \> 380 µm and \< 400 µm thinnest location) were assigned into Epi-on Trans-epithelial accelerated CXL procedure

Procedure: Accelerated corneal collagen cross linking

Interventions

Accelerated corneal collagen cross linking PROCEDURE

This strategy is based on the underlying pathology of the disease. Corneal collagen cross linking (CXL) idea was based on the fact that a photosensitizer substance like riboflavin (vitamin B2) can interact with ultraviolet irradiation (Ultraviolet-A) to strengthen the corneal tissue inter and intrafibrillar collagen bonds thus preventing further thinning, corneal protrusion and reduces corneal irregular astigmatism.

Group 1 (Epithelium-off accelerated CXL); Group 2 (Epithelium-on accelerated CXL)

Eligibility Criteria

• Age: 15 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with progressive keratoconus (maximum K-reading between 46 diopters and 56 diopters), clear cornea and corneal pachymetry \> 380um.

You may not qualify if:

• Corneal scarring.
• Advanced keratoconus (k-max \> 56 D).
• Corneal pachymetry (thinnest location) \< 380 µm.
• Epithelial healing disorders e.g.
• Recurrent corneal erosion syndrome.
• History of diseases that may delay corneal healing or predispose the eye for future complications (e.g. rheumatic disorders, glaucoma, uveitis, chemical burn, corneal dystrophy).
• History suggestive of herpetic keratitis because the UVR can activate herpes virus.
• Post-LASIK ectasia and/or previous corneal surgeries e.g. intrastromal corneal ring segments (INTACS).
• Pregnancy and breast-feeding.

Sponsors & Collaborators

• Reham Mahmoud Abdelrahman: lead

Study Sites (1)

Teba private eye centre

Asyut, 71111, Egypt

RECRUITING

Related Publications (3)

• Mrochen M. Current status of accelerated corneal cross-linking. Indian J Ophthalmol. 2013 Aug;61(8):428-9. doi: 10.4103/0301-4738.116075.

  PMID: 23925330 RESULT

• Li Y, Meisler DM, Tang M, Lu AT, Thakrar V, Reiser BJ, Huang D. Keratoconus diagnosis with optical coherence tomography pachymetry mapping. Ophthalmology. 2008 Dec;115(12):2159-66. doi: 10.1016/j.ophtha.2008.08.004. Epub 2008 Nov 5.

  PMID: 18977536 RESULT

• Greenstein SA, Shah VP, Fry KL, Hersh PS. Corneal thickness changes after corneal collagen crosslinking for keratoconus and corneal ectasia: one-year results. J Cataract Refract Surg. 2011 Apr;37(4):691-700. doi: 10.1016/j.jcrs.2010.10.052.

  PMID: 21420594 RESULT

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Kamel Abdelnaser, MD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Kamel Abdelnaser, MD

CONTACT

00201064848401; kamel.atya@med.au.edu.eg

Mohammed S Saad, MD

CONTACT

00201001825024; mohsayedsaad@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 18, 2019
• Study Start: October 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 30, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)