NCT06549387Not yet recruitingNot Applicable
Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
Kasr El Aini Hospital1 site in 1 country55 target enrollmentStarted: August 15, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Change in the endothelial cell count.
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
The standard accelerated CXL (aCXL) protoco
Active Comparator
Intervention: Corneal cross linking (Procedure)
Progressive Fluence Epi-on accelerated crosslinking M nomogram
Active Comparator
Intervention: Corneal cross linking (Procedure)
The topo-pachimetric customized accelerated epithelium-On (aCFXL group)
Active Comparator
Intervention: Corneal cross linking (Procedure)
Outcomes
Primary Outcomes
Change in the endothelial cell count.
Time Frame: 6 months
the stability or decrease in the endothelial cell count.
Amount of corneal flattening
Time Frame: 6 months
Kmax flattening
Secondary Outcomes
- Best corrected visual acuity(6 months)
Investigators
Paula Sameh Youssef
M.Sc.
Kasr El Aini Hospital
Study Sites (1)
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