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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06159881

Enrollment

Registered

2023-12-07

Start date

2023-03-01

Completion date

2024-05-15

Last updated

2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Progression, Customized, Cross-Linking

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

Interventions

PROCEDURECorneal Cross Linking

Total fluence adapted to thinnest point pachymetry

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
Corneal endothelium safety	Baseline, 72 hours, 1 week, 3 months and 6 months	Corneal endothelial cell count obtained by specular microscopy

Countries

Mexico

Contacts

Primary ContactItamar Vigderovich, MD

vigderovich@gmail.com+52 5519491905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026