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NCT Number: NCT05849974

Large Cohort of 1000 Patients With Severe Myopia

The prevalence of myopia and severe myopia are increasing and will affect 50% and 10% of the population respectively. Severe myopia exposes an increased risk of glaucoma, cataract, retinal detachment and myopic maculopathy, a source of visual impairment.

To date, no European cohort study has been conducted to estimate the rate of these complications and to study the predictive parameters.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study allows to describe the evolution of different ophthalmological parameters of a population of strong myopes during their follow-up for 10 years using multimodal imaging techniques of the retina.

Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection.

This study will include major and minor patients with high myopia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 6 years
  • Severe myopia in at least one eye, defined as
  • a refractive error ≤ -6.00 diopters OR
  • an axial length ≥ 26.50 mm
  • Follow-up performed at at least one of the participating centers
  • Express consent to participate in the study
  • If age < 18 years: express consent of the person(s) exercising parental authority
  • Affiliated or beneficiary of a health insurance

Exclusion criteria

  • Visual acuity < 5 letters on the ETDRS (equivalent to "finger count" or less) in both eyes
  • Disorders of the transparent media in both eyes with opacities that may affect image quality
  • Syndromic myopia of genetic origin (Stickler syndrome type 1 and 2, Marfan syndrome, Ehler-Danlos disease type 4, Knobloch syndrome) or inherited retinal dystrophy (X-linked retinitis pigmentosa, congenital stationary night blindness of Schubert-Bornshein type, Bornholm eye disease)
  • Patient who does not wish to continue to be followed in one of the participating centers
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Treatment and study plan

Structural and fonctional phynotyping

Other

The additioan acts in this research are:

Fonctionnal phenotyping:Retinal sensitivity and fixation stability assessment using microperimetry, assessment of long-term fixation stability Structural Phenotyping: Anterior segment examination with OCT anterior Blood sample collection

Primary outcomes

  1. Visual acuity

    Time frame: 10 years

    Using the ETDRS and the near vision scale (decimal scales converted to logMAR)

  2. Refraction measures

    Time frame: 10 years

    Measure will be performed in diopter

  3. Lens opacity

    Time frame: 10 years

    Measure will be performed in pixel units

  4. Intraocular pressure and pachymetry

    Time frame: 10 years

    These measurements are respectively carried out in mmHg and in μm

  5. Retinal sensitivity and fixation stability

    Time frame: 10 years

    Respectively Performed in decibels and by microperimetry

  6. Central visual field deficits

    Time frame: 10 years

    by automatic perimetry in decibels

  7. Axial length

    Time frame: 10 years

    Will be performed in mm

  8. Quantitative data

    Time frame: 10 years

    On optical coherence tomography (OCT) and OCT-Angiography

  9. qualitative data on OCT :

    Time frame: 10 years

    presence of any macular complications:

    • condition of the posterior vitreous
    • presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).
  10. Area of Rétinal atrophy

    Time frame: 10 years

    In autofluorescence (in mm²)

  11. Characterization of the type of staphyloma

    Time frame: 10 years

    staphyloma classification

  12. Vitreous status

    Time frame: 10 years

    Liquefaction, stage of posterior vitreous detachment

  13. Excavation of the optic nerve and area

    Time frame: 10 years

    In mm² of peripapillary atrophy on color and autofluorescence images

  14. Anterior segment status

    Time frame: 10 years

    Chamber measurement, corneal curvature (in mm)

Secondary outcomes

  1. Macular ophthalmologic complications

    Time frame: 10 years

    Diffuse atrophy/patch atrophy/macular atrophy

    • Choroidal neovessel
    • Bruch's membrane rupture
    • Bulging macula
    • Papillary dysversion
    • Myopic staphyloma
    • Epiretinal membrane
    • Lamellar hole
    • Myopic foveoschisis
    • Macular hole
  2. Non-macular ophthalmologic complications

    Time frame: 10 years

    • Glaucoma optic Neuropathy
    • Cataract
    • Retinal detachment

Study contacts

Contact information is provided by the study sponsor or research team.

Hayet SERHANE

CONTACT

[email protected]

+331 40 02 11 44

Nabil BROUK

CONTACT

[email protected]

+331 40 02 11 26

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Registry information

Acronym: MyoCo1000

Important dates

Study start
2023
Primary completion
2038
Study completion
2038
First posted
May 9, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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