Clinical trial NCT05717673: Effect of Epi-Off Technique Corneal CXL On Endothelial Count by Specular Microscopy in Keratoconus Patients
Official title: Effect of Epi-Off Technique in Corneal Collagen Cross Linking On Endothelial Count by Using Specular Microscopy in Keratoconus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keratoconus, Collagen
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine safety of CXL on corneal endothelial count by using specular microscopy in patients with keratoconus
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university
Study officials:
affiliation: Assiut University
name: Mohammed Aly Momen
role: STUDY_DIRECTOR
References: