Risk Factors for Inter-eye Asymmetry in Keratoconus Severity (ASYMECONE)

March 11, 2026 updated by: Centre Hospitalier Régional Metz-Thionville
Observational study comparing patients with inter-eye asymmetric keratoconus with patients with inter-eye symmetric keratoconus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed description: Keratoconus is a condition resulting in corneal thinning and visual impairment due to irregular astigmatism. Most cases are bilateral, although the severity is often asymmetric between both eyes. The aim of our study is to examine risk factors for inter-eye asymmetry in terms of severity in patients with a confirmed diagnosis of keratoconus. Patients were reviewed for keratoconus staging for each eye according to the Amsler-Krumeich classification to define asymmetry and separated in groups according to the laterality of the worst eye and in a group where both eyes were symmetric in terms of asymmetry. A multivariate logistic regression was performed on various risk factors to explore keratoconus inter-eye asymmetry.

Study Type

Observational

Enrollment (Actual)

154

Contacts and Locations

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

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz-Thionville Hopital de Mercy

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the attending ophthalmologist during the study period with previously diagnosed unilateral or bilateral keratoconus or patients newly diagnosed with unilateral or bilateral keratoconus during the study period.

Description

Inclusion Criteria:

  • Patients presenting to the attending ophthalmologist during the study period with previously diagnosed unilateral or bilateral keratoconus
  • Patients newly diagnosed with unilateral or bilateral keratoconus during the study period.

Exclusion Criteria:

  • Previous corneal surgery
  • Previous corneal crosslinking
  • Previous keratoplasty
  • Previous placement of intrastromal corneal rings

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort of Patients with keratoconus
Patients presenting to the attending ophthalmologist during the study period with previously diagnosed unilateral or bilateral keratoconus or (ii) patients newly diagnosed with unilateral or bilateral keratoconus during the study period.
Behavioral: Questionnaire
Questionnaire about eye rubbing habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for inter-eye keratoconus asymmetry in terms of severity
Time Frame: Day 1
Logistic regression
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Jean-Marc PERONE, MD, CHR Metz-Thionville Hopital de Mercy

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)

January 1, 2020

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-04Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

According to French law and the guidelines of the French Data Protection Authority (CNIL), individual participant data cannot be publicly shared. However, study findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

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.

Clinical Trials on Keratoconus

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe