NCT02583620

Brief Summary

Compelling evidence of genetic components in high myopia has been put forward by several studies. Twin cohorts, familial linkage studies and population studies has described at least 10 loci containing genes involved in the disease development. The investigators previously demonstrated novel linkage on chromosome 7q36 and chromosome 7p15 in French families. A new approach consisting of a case-control based population association study is underway in order to recover a high number of myopic subjects avoiding the limitation of familial cases. 1.8 millions polymorphic markers will be compared with emmetropic controls in order to recover loci associated with the disease in the population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
553

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

September 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

5 years

First QC Date

August 18, 2015

Last Update Submit

October 20, 2015

Conditions

Myopia

Keywords

high myopia

Outcome Measures

Primary Outcomes (1)

  • Numbers of allele frequencies at markers in the population

    Numbers of allele frequencies at markers in the population

    Baseline

Study Arms (2)

Emmetropic volunteers

OTHER

Blood sample

Genetic: blood sample

High myopic volunteers

OTHER

Blood sample

Genetic: blood sample

Interventions

blood sampleGENETIC

A blood test is realized on the subject

Emmetropic volunteersHigh myopic volunteers

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high myopic (cases) volunteers,
  • emmetropic (controls) volunteers

You may not qualify if:

  • syndromic myopic children under 18 years,
  • non autonomous adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Pointe-à-Pitre

Pointe à Pitre, Guadeloupe, 97139, France

Location

CHU Bordeaux Hôpital Pellegrin

Bordeaux, 33076, France

Location

CHU Limoges Hôpital Dupuytren

Limoges, 87042, France

Location

CHU Toulouse Hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Myopia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • François MALECAZE, PhD, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2015

First Posted

October 22, 2015

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

FR(4)