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Large Cohort of 1000 Patients With Severe Myopia (MyoCo1000)

Primary Purpose

Myopia, Severe

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structural and fonctional phynotyping
Sponsored by
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia, Severe

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hight Myopa

    Arm Description

    Large Cohort of patients with hight Myopa

    Outcomes

    Primary Outcome Measures

    Visual acuity
    Using the ETDRS and the near vision scale (decimal scales converted to logMAR)
    Refraction measures
    Measure will be performed in diopter
    Lens opacity
    Measure will be performed in pixel units
    Intraocular pressure and pachymetry
    These measurements are respectively carried out in mmHg and in μm
    Retinal sensitivity and fixation stability
    Respectively Performed in decibels and by microperimetry
    Central visual field deficits
    by automatic perimetry in decibels
    Axial length
    Will be performed in mm
    Quantitative data
    On optical coherence tomography (OCT) and OCT-Angiography
    qualitative data on OCT :
    presence of any macular complications: condition of the posterior vitreous presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).
    Area of Rétinal atrophy
    In autofluorescence (in mm²)
    Characterization of the type of staphyloma
    staphyloma classification
    Vitreous status
    Liquefaction, stage of posterior vitreous detachment
    Excavation of the optic nerve and area
    In mm² of peripapillary atrophy on color and autofluorescence images
    Anterior segment status
    Chamber measurement, corneal curvature (in mm)

    Secondary Outcome Measures

    Macular ophthalmologic complications
    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
    Non-macular ophthalmologic complications
    Glaucoma optic Neuropathy Cataract Retinal detachment

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Collaborators
    Fondation Ophtalmologique Adolphe de Rothschild
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05849974
    Brief Title
    Large Cohort of 1000 Patients With Severe Myopia
    Acronym
    MyoCo1000
    Official Title
    Large Cohort of 1000 Patients With Severe Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    May 2038 (Anticipated)
    Study Completion Date
    May 2038 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Collaborators
    Fondation Ophtalmologique Adolphe de Rothschild

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Severe

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection. This study will include major and minor patients with high myopia
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hight Myopa
    Arm Type
    Experimental
    Arm Description
    Large Cohort of patients with hight Myopa
    Intervention Type
    Other
    Intervention Name(s)
    Structural and fonctional phynotyping
    Intervention Description
    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 Outcome Measure Information:
    Title
    Visual acuity
    Description
    Using the ETDRS and the near vision scale (decimal scales converted to logMAR)
    Time Frame
    10 years
    Title
    Refraction measures
    Description
    Measure will be performed in diopter
    Time Frame
    10 years
    Title
    Lens opacity
    Description
    Measure will be performed in pixel units
    Time Frame
    10 years
    Title
    Intraocular pressure and pachymetry
    Description
    These measurements are respectively carried out in mmHg and in μm
    Time Frame
    10 years
    Title
    Retinal sensitivity and fixation stability
    Description
    Respectively Performed in decibels and by microperimetry
    Time Frame
    10 years
    Title
    Central visual field deficits
    Description
    by automatic perimetry in decibels
    Time Frame
    10 years
    Title
    Axial length
    Description
    Will be performed in mm
    Time Frame
    10 years
    Title
    Quantitative data
    Description
    On optical coherence tomography (OCT) and OCT-Angiography
    Time Frame
    10 years
    Title
    qualitative data on OCT :
    Description
    presence of any macular complications: condition of the posterior vitreous presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).
    Time Frame
    10 years
    Title
    Area of Rétinal atrophy
    Description
    In autofluorescence (in mm²)
    Time Frame
    10 years
    Title
    Characterization of the type of staphyloma
    Description
    staphyloma classification
    Time Frame
    10 years
    Title
    Vitreous status
    Description
    Liquefaction, stage of posterior vitreous detachment
    Time Frame
    10 years
    Title
    Excavation of the optic nerve and area
    Description
    In mm² of peripapillary atrophy on color and autofluorescence images
    Time Frame
    10 years
    Title
    Anterior segment status
    Description
    Chamber measurement, corneal curvature (in mm)
    Time Frame
    10 years
    Secondary Outcome Measure Information:
    Title
    Macular ophthalmologic complications
    Description
    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
    Time Frame
    10 years
    Title
    Non-macular ophthalmologic complications
    Description
    Glaucoma optic Neuropathy Cataract Retinal detachment
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nabil BROUK
    Phone
    +331 40 02 11 26
    Email
    nbrouk@15-20.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hayet SERHANE
    Phone
    +331 40 02 11 44
    Email
    hserhane@15-20.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ramin TADAYONI, Pr
    Organizational Affiliation
    Hôpital Fondation Adolphe de Rothschild
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Large Cohort of 1000 Patients With Severe Myopia

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