Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.

ConditionHigh Myopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any systemic or ocular pathologies with an impact on the posterior segment of the eye

Diabetes

Systemic inflammatory disease: sarcoidosis, rheumatoid arthritis, systemic lupus erythematosus, Horton's disease

Patients with retinitis pigmentosa

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sampling for DNA

    Biological/Vaccine

    Blood sampling for DNA and serum and plasma colection and PBMC

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AM A : High Myopia without myopic staphylomaExperimental treatment 1 intervention
Group B: ARM B : High myopia with myopic staphylomaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Differential gene expression between myopic patients with and without staphyloma

Genetic analysis

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

Establish correlations between the phenotype and systemic molecular markers

Proteomic analysis in blood

Time frame
Through study completion, an average of 1 year.
2

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

Retinal imaging

Time frame
25 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator