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

Sponsor
Heba Allah Nashaat Mohamed (Other)
Overall Status
Recruiting
CT.gov ID
NCT05717673
Collaborator
Assiut University (Other)
30
1
7
4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Epi-Off Technique in Corneal Collagen Cross Linking On Endothelial Count by Using Specular Microscopy in Keratoconus Patients
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 5, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus [6 months]

    by using specular microscopy to assess endothelial count to prevent corneal damages

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuit university Assiut Egypt 088

Sponsors and Collaborators

  • Heba Allah Nashaat Mohamed
  • Assiut University

Investigators

  • Study Director: Mohammed Aly Momen, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heba Allah Nashaat Mohamed, Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus, Assiut University
ClinicalTrials.gov Identifier:
NCT05717673
Other Study ID Numbers:
  • EOEOCXLOEnCBsMK
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023