Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management

N/ANot Yet RecruitingNCT06549387

Kasr El Aini Hospital55 enrolled

Overview

The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amount of Corneal Flattening (Kmax Flattening)Change in the Endothelial Cell Count

Interventions

Corneal cross linkingPROCEDURE

Applying UVA irradiation to the cornea after soaking with riboflavin

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18 years or older 2. Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen. 3. Central corneal thickness (de-epithelialized) of ≥ 400 micron. 4. Corneal endothelial count of ≥ 2000. Exclusion Criteria: 1. Previous eye surgery 2. The presence of lesions other than keratoconus, central or paracentral scaring 3. History of Cross linking 4. History of viral keratitis 5. Connective tissue diseases 6. Pregnancy or lactation during the study. 7. The presence of nystagmus

Locations (1)

Kasr Al Ainy

Cairo, Egypt

Outcomes

Primary Outcomes

Amount of corneal flattening

Kmax flattening

Time frame: 6 months

Change in the endothelial cell count.

the stability or decrease in the endothelial cell count.

Time frame: 6 months

Secondary Outcomes

Best corrected visual acuity

Time frame: 6 months

Data from ClinicalTrials.gov

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