Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Enrolling

Conditions: Keratoconus

Treatments: Procedure: Corneal Cross Linking

Study type: Interventional

Funder types: Other

Identifiers

NCT06159881

17 CI 09 015 008

Details and patient eligibility

About

The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:

• Is it effective while using personalized (reduced) energy?
• Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Keratoconus diagnosed with corneal tomography/topography
• Thinnest point pachymetry below 400 microns

Exclusion criteria

• Previous corneal cross linking history
• Corneal scars not allowing best corrected visual acuity of 20/100 or better
• Previous corneal hydrops history
• Psychomotor retardation history

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Personalized cross linking

Experimental group

Description:

Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry

Treatment:

Procedure: Corneal Cross Linking