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

K

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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