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

Not Applicable

Not yet recruiting

• Conditions: Amount of Corneal Flattening (Kmax Flattening); Change in the Endothelial Cell Count
• Interventions: Procedure: Corneal cross linking

• Registration Number: NCT06549387
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Study Start: 2024-08-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The topo-pachimetric customized accelerated epithelium-On (aCFXL group)	Corneal cross linking	-
The standard accelerated CXL (aCXL) protoco	Corneal cross linking	-
Progressive Fluence Epi-on accelerated crosslinking M nomogram	Corneal cross linking	-

Primary Outcome Measures

Name	Time	Method
Change in the endothelial cell count.	6 months	the stability or decrease in the endothelial cell count.
Amount of corneal flattening	6 months	Kmax flattening

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	6 months

Trial Locations

Locations (1)

Kasr Al Ainy; 🇪🇬 Cairo, Egypt