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Search / Trial NCT06949579

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 25, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

High Myopia Myopic Staphyloma

ClinConnect Summary

This clinical trial is studying a condition called high myopia, which is a severe form of nearsightedness that can lead to serious eye problems, including a condition known as posterior staphyloma. The goal of the study is to better understand how common this condition is among highly nearsighted individuals in Europe by collecting information from patients who visit specific eye clinics in the Netherlands, Spain, and France. The research will involve about 600 adult participants who have high myopia, which means their eyeball is longer than normal or their eyesight is very poor.

To participate, individuals must be at least 18 years old and have high myopia with good quality eye imaging. They will need to sign a consent form to be part of the study. Participants can expect to receive standard eye care, and they may also provide a blood sample for further analysis. It’s important to note that certain health conditions, like diabetes or other eye diseases, may prevent someone from joining the study. All information collected during the trial will be stored in a secure online database to ensure privacy and accuracy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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).

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Francine BEHAR-COHEN, MD,PhD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported