Health TrialsbyHealthPanel

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

ConditionsAmount of Corneal Flattening (Kmax Flattening)Change in the Endothelial Cell Count
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKasr El Aini Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Previous eye surgery

The presence of lesions other than keratoconus, central or paracentral scaring

History of Cross linking

History of viral keratitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Corneal cross linking

    Procedure/Surgery

    Applying UVA irradiation to the cornea after soaking with riboflavin

Treatment groups

55 Participants
are divided into 3 treatment groups
Group A: The topo-pachimetric customized accelerated epithelium-On (aCFXL group)Active comparator 1 intervention
Group B: The standard accelerated CXL (aCXL) protocoActive comparator 1 intervention
Group C: Progressive Fluence Epi-on accelerated crosslinking M nomogramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Amount of corneal flattening

Kmax flattening

Time frame
6 months
2

Change in the endothelial cell count.

the stability or decrease in the endothelial cell count.

Time frame
6 months

Secondary outcomes

1

Best corrected visual acuity

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kasr El Aini Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: