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

December 5, 2023 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto de Oftalmología Conde de Valenciana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized cross linking
Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry
Procedure: Corneal Cross Linking
Total fluence adapted to thinnest point pachymetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratometry stability
Time Frame: 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
Baseline and 6 months
Pachymetry stability
Time Frame: Baseline and 6 months
Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography
Baseline and 6 months
Uncorrected visual acuity stability
Time Frame: 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
Baseline, 72 hours, 1 week, 3 months and 6 months
Corneal endothelium safety
Time Frame: Baseline, 72 hours, 1 week, 3 months and 6 months
Corneal endothelial cell count obtained by specular microscopy
Baseline, 72 hours, 1 week, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

  • Study Director: Enrique Graue, MD, MSc, Instituto de Oftalmología Conde de Valenciana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17 CI 09 015 008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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