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

Not Applicable

Recruiting

• Conditions: Keratoconus
• Interventions: Procedure: Corneal Cross Linking

• Registration Number: NCT06159881
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-11-28
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized cross linking	Corneal Cross Linking	Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry

Primary Outcome Measures

Name	Time	Method
Corneal endothelium safety	Baseline, 72 hours, 1 week, 3 months and 6 months	Corneal endothelial cell count obtained by specular microscopy
Keratometry stability	Baseline and 6 months	Stability documented by changes in keratometries (measured in diopters) obtained with corneal tomography, as well as uncorrected visual acuity observed in follow up consults
Pachymetry stability	Baseline and 6 months	Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography
Uncorrected visual acuity stability	Baseline, 72 hours, 1 week, 3 months and 6 months	Stability documented by changes in uncorrected visual acuity (measured in logarithm of the minimum angle of resolution) obtained on physical examiantion

Trial Locations

Locations (1)

Instituto de Oftalmología Conde de Valenciana; 🇲🇽 Mexico City, Mexico