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NCT Number: NCT06549387

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

corneal cross linking

Procedure

Applying UVA irradiation to the cornea after soaking with riboflavin

Primary outcomes

  1. Amount of corneal flattening

    Time frame: 6 months

    Kmax flattening

  2. Change in the endothelial cell count.

    Time frame: 6 months

    the stability or decrease in the endothelial cell count.

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.