NCT06949579

Brief Summary

In this cross-sectionnal study the aim is to increase the understanding of posterior staphyloma through a unique European consortium. Therefore, all eligible patients that either visit the outpatient clinic at Radboud in Nimegen, the Netherlands, or visit University Hopital Puerta de HierroMajadahonda in Madrid, Spain, or visit University Hospital Cochin in Paris, France, and after consenting, will be included. 600 high myopic European cases are expecting. A standardized protocol in all centers in order to create a uniform dataset. Besides the standard of care, blood samples will be collected. All data collected will be stored in an onlie Castor database

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

March 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 24, 2025

Last Update Submit

March 30, 2026

Conditions

High Myopia

Keywords

High myopiaMyopic staphyloma

Outcome Measures

Primary Outcomes (1)

  • Differential gene expression between myopic patients with and without staphyloma

    Genetic analysis

    Through study completion, an average of 1 year.

Secondary Outcomes (2)

  • Establish correlations between the phenotype and systemic molecular markers

    Through study completion, an average of 1 year.

  • Compare phenotype of staphyloma between France and 2 other European countries: Netherlands and Spain

    25 months

Study Arms (2)

AM A : High Myopia without myopic staphyloma

EXPERIMENTAL
Biological: blood sampling for DNA

ARM B : High myopia with myopic staphyloma

ACTIVE COMPARATOR
Biological: blood sampling for DNA

Interventions

blood sampling for DNABIOLOGICAL

Blood sampling for DNA and serum and plasma colection and PBMC

AM A : High Myopia without myopic staphylomaARM B : High myopia with myopic staphyloma

Eligibility Criteria

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

You may qualify if:

  • Adults with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with and without posterior staphyloma
  • Adults aged 18 years or over
  • Patient with high myopia (axial length ≥ 26.00 mm or degree of myopia of at least -6 diopters), with good quality retinal imaging
  • Patient who has signed a consent form to participate in the study
  • Patient who is a beneficiary of a social security scheme or who is entitled to it

You may not qualify if:

  • Any systemic or ocular pathologies with an impact on the posterior segment of the eye
  • Patient with a systemic pathology likely to affect the posterior segment of the eye:
  • Diabetes
  • Systemic inflammatory disease: sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, Horton's disease
  • Patients with retinitis pigmentosa
  • Patients with syndromic myopia
  • Patients with myopia associated with a genetic disease such as hereditary vitreoretinopathy
  • Patients under guardianship, curatorship or legal protection, as well as pregnant or breastfeeding women (article L1121-5 of the CSP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen CollectionDNA

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesNucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Francine BEHAR-COHEN, MD,PhD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francine Behar-Cohen, MD, PhD

CONTACT

06 60 97 44 19francine.cohen@aphp.fr

Valérie PLENCE, Msc

CONTACT

01 58 41 11 78valerie.plence-fauroux@aphp.fr

Study Design

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

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 29, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)