NCT07468253

Brief Summary

Observational study comparing patients with inter-eye asymmetric keratoconus with patients with inter-eye symmetric keratoconus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 6, 2026

Last Update Submit

March 11, 2026

Conditions

Keratoconus

Keywords

keratoconusAsymmetry

Outcome Measures

Primary Outcomes (1)

  • Risk factors for inter-eye keratoconus asymmetry in terms of severity

    Logistic regression

    Day 1

Study Arms (1)

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

Interventions

QuestionnaireBEHAVIORAL

Questionnaire about eye rubbing habits

cohort of Patients with keratoconus

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Marc PERONE, MD

    CHR Metz-Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

January 1, 2020

Primary Completion

February 27, 2023

Study Completion

February 27, 2023

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

FR(1)