Eye Rubbing and Keratoconus in Montpellier CHU | NCT04249180

Studies
Eye Rubbing and Keratoconus in Montpellier CHU

NCT04249180

Sponsor

University Hospital, Montpellier

Status

Withdrawn

Last Update Posted

Jul 29, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

CPP

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Jan 28, 2020

First Submission Date that Met QC Criteria

Jan 28, 2020

First Posted Date

Jan 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2020

Last Update Posted Date

Jul 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess whether eye rubbing is a risk factor for keratoconus	Assess whether eye rubbing is a risk factor for keratoconus	1 day

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the habits of the population with a keratoconus	Evaluate the habits of the population with a keratoconus by a questionnaire completed by the patient	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Having a keratonus at least in one eyes

Exclusion criteria:

- Refus to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient is having a keratoconus in at least one eye. It is a deases with a primitive corneal ectasia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel Planells, Internship of ophthalmology	University Hospitals of Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007640	Keratoconus

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided