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

Kasr El Aini Hospital

Status: Not yet enrolling

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

Treatments: Procedure: Corneal cross linking

Study type: Interventional

Funder types: Other

Identifiers

NCT06549387

_MD-402-2023_

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

The topo-pachimetric customized accelerated epithelium-On (aCFXL group)

Active Comparator group

Treatment:

Procedure: Corneal cross linking

The standard accelerated CXL (aCXL) protoco

Active Comparator group

Treatment:

Procedure: Corneal cross linking

Progressive Fluence Epi-on accelerated crosslinking M nomogram

Active Comparator group

Treatment:

Procedure: Corneal cross linking