Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Corneal cross linking.
- Who it may be relevant to
- Registry conditions: Amount of Corneal Flattening (Kmax Flattening), Change in the Endothelial Cell Count. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
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.
Interventions
- Procedure Corneal cross linking
Applying UVA irradiation to the cornea after soaking with riboflavin
Primary outcome measures
- Amount of corneal flattening [Time frame: 6 months]
- Change in the endothelial cell count. [Time frame: 6 months]
Secondary outcome measures (1)
- Best corrected visual acuity [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age: 18 years or older
- Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
- Central corneal thickness (de-epithelialized) of ≥ 400 micron.
- Corneal endothelial count of ≥ 2000.
Exclusion criteria
- Previous eye surgery
- The presence of lesions other than keratoconus, central or paracentral scaring
- History of Cross linking
- History of viral keratitis
- Connective tissue diseases
- Pregnancy or lactation during the study.
- The presence of nystagmus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kasr Al Ainy — Cairo
Identifiers
NCT: NCT06549387 · _MD-402-2023_