Effect of Epi-Off Technique Corneal CXL On Endothelial Count by Specular Microscopy in Keratoconus Patients

Effect of Epi-Off Technique in Corneal Collagen Cross Linking On Endothelial Count by Using Specular Microscopy in Keratoconus Patients

Determine safety of EPi-off CXL on corneal endothelium by using specular specular microscopy to assess endothelial count.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus, Collagen
• Intervention / Treatment: Device: Specular microscopy

Detailed Description

Specular microscopy is a noninvasive photographic technique that analyze the corneal endothelium. Using computer-assisted morphometry, modern specular microscopes analyze the size, shape and population of the endothelial cells. The instrument projects light onto the cornea and captures the image that is reflected from the optical interface between the corneal endothelium and the aqueous humor. The reflected image is analyzed by the instrument and displayed as a specular photomicrograph

Corneal collagen cross-linking (CXL) is a therapeutic procedure aiming at increasing the corneal stiffness in the keratoconus eyes by induction of cross-links within the extracellular matrix. It is achieved by ultraviolet-A (370 nm) irradiation of the cornea after saturation with the photosensitizer riboflavin. In the conventional CXL protocol, a minimum (manual) de-epithelialized corneal thickness of 400 μm is recommended to avoid potential irradiation damage to the corneal endothelium. In advanced keratoconus, however, stromal thickness is often lower than 400 μm, which limits the application of CXL in that category. Efforts have been undertaken to modify the conventional CXL procedure to be applicable in thin corneas. The current review discusses different techniques employed to achieve this end and their results. The overall safety and efficacy of the modified CXL protocols are good, as most of them managed to halt the progression of keratectasia without postoperative complications. However, the evidence of safety and efficacy in the use of modified CXL protocols is still limited to few studies with few patients involved. Controlled studies with long-term follow-up are required to confirm the safety and efficacy of it.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Wael Mo Soliman, Md; Phone Number: 0106 55665302; Email: wael.soliman@med.au.edu.eg
• Study Contact Backup: Name: Dalia mo elsebati, Md; Phone Number: 01223212962; Email: drdalia@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 088
    • Recruiting
    • Assuit University
    • Contact: Wael Mo Soliman, Md; Phone Number: 0106 55665302; Email: wael.soliman@med.au.edu.eg
    • Contact: Dalia mo elsebati, Md; Phone Number: 01223212962; Email: drdalia@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People have keratoconus from 10 years to 75 years has corneal thickness more than 400 um at the thinnest location of the cornea with exclusion criteria like prior herpetic infection or autoimmune disease or corneal opacity

Description

Inclusion Criteria:

• Patients with corneal diseases that treated by collagen cross linking such as keratokonus and post lasic ectesia with corneal thickness above 400um at its thinnest location.

Exclusion Criteria:

1. Prior herpetic infection
2. Autoimmune disorders
3. corneal thickness below 400um at its thinnest location
4. Corneal opacity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus	by using specular microscopy to assess endothelial count to prevent corneal damages	6 months

Collaborators and Investigators

• Sponsor: Heba Allah Nashaat Mohamed
• Collaborators: Assiut University
• Investigators: Study Director: Mohammed Aly Momen, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): May 5, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: EOEOCXLOEnCBsMK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No