NCT03464994

Brief Summary

Presence/absence of subclinical keratoconus with corneal topographic abnormalities (skewed radial axes for forme fruste keratoconus, and inferior steepening for keratoconus suspect) on axial specular topography (TMS-4 Tomey), and elevation topographies: Pentacam (Oculus) and Orbscan (Bausch \& Lomb).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

July 18, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

November 18, 2017

Last Update Submit

December 23, 2025

Conditions

Ichthyosis

Keywords

Hereditary ichthyosiskeratoconus

Outcome Measures

Primary Outcomes (1)

  • Presence/absence of subclinical keratoconus

    Presence/absence of subclinical keratoconus with corneal topographic abnormalities (skewed radial axes for forme fruste keratoconus, and inferior steepening for keratoconus suspect) on axial specular topography (TMS-4 Tomey), and elevation topographies: Pentacam (Oculus) and Orbscan (Bausch \& Lomb).

    10 mn

Secondary Outcomes (5)

  • Presence/absence of symptomatic keratoconus with irregular topographic maps

    10 mn

  • Presence/absence of an abnormality of corneal transparency

    10 mn

  • Presence/absence of sicca syndrome

    10 mn

  • Evaluation of quality of vision

    10 mn

  • Quality of life for adults

    10 mn

Study Arms (2)

ichthyosis patients

OTHER

patients presenting an Hereditary ichthyosis, whatever form or ongoing therapy will have an ophthalmological examination.

Diagnostic Test: ophthalmological examination

control population

OTHER

patient without ichthyosis disease and consulting an ophthalmologist for refractive surgery screening or systematic eye examination will have an ophthalmological examination

Diagnostic Test: ophthalmological examination

Interventions

ophthalmological examinationDIAGNOSTIC_TEST

* Refraction * Best corrected visual acuity * Intraocular pressure * Slit lamp examination with vital dye (Oxford grading) * Tear break-up time (TBUT) * Schirmer I testing * Specular (TMS-4 Tomey) and elevation (pentacam Oculus and Orbscan Bausch \& Lomb) corneal videotopographies * Pachymetry * Questionnaires: Ocular surface disease index, quality of vision (visual analogic scale), and quality of life (NEI-VFQ25) * questionnaire about ichthyosis severity * questionnaire about life quality specifically for patient presenting ichthyosis

control populationichthyosis patients

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For ichthyosis population:
  • Hereditary ichthyosis, whatever form or ongoing therapy.
  • Parental permission for minors
  • For controls:
  • Patients who consult an ophthalmologist for refractive surgery screening or systematic eye examination
  • Parental permission for minors

You may not qualify if:

  • For both populations:
  • Patient who cannot stay seated
  • Wearing contact lens within the last 7 days
  • No social security
  • Past medical history of corneal or eye surgery or eye condition (glaucoma, uveitis, keratoconus, retinal diseases)
  • Impossibility to fill the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

IchthyosisKeratoconus

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue DiseasesCorneal DiseasesEye Diseases

Study Officials

  • Juliette MAZEREEUW, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2017

First Posted

March 14, 2018

Study Start

July 18, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

FR(1)