Myopia, SevereMyoCo1000NCT05849974
Large Cohort of 1000 Patients With Severe Myopia
A study testing Structural and fonctional phynotyping in people with Myopia, Severe, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Myopia, Severe
- What is being tested?
- Structural and fonctional phynotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to May 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Myopia, Severe
- Being tested
- Structural and fonctional phynotyping
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural and fonctional phynotypingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hight Myopa | Experimental | Large Cohort of patients with hight Myopa Receives: Other: Structural and fonctional phynotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Using the ETDRS and the near vision scale (decimal scales converted to logMAR)
Measured: 10 years
Refraction measures
Measure will be performed in diopter
Measured: 10 years
Lens opacity
Measure will be performed in pixel units
Measured: 10 years
Intraocular pressure and pachymetry
These measurements are respectively carried out in mmHg and in μm
Measured: 10 years
Retinal sensitivity and fixation stability
Respectively Performed in decibels and by microperimetry
Measured: 10 years
Central visual field deficits
by automatic perimetry in decibels
Measured: 10 years
Axial length
Will be performed in mm
Measured: 10 years
Quantitative data
On optical coherence tomography (OCT) and OCT-Angiography
Measured: 10 years
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...).
Measured: 10 years
Area of Rétinal atrophy
In autofluorescence (in mm²)
Measured: 10 years
Characterization of the type of staphyloma
staphyloma classification
Measured: 10 years
Vitreous status
Liquefaction, stage of posterior vitreous detachment
Measured: 10 years
Excavation of the optic nerve and area
In mm² of peripapillary atrophy on color and autofluorescence images
Measured: 10 years
Anterior segment status
Chamber measurement, corneal curvature (in mm)
Measured: 10 years
Secondary outcomes (2)
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
Measured: 10 years
Non-macular ophthalmologic complications
- Glaucoma optic Neuropathy
- Cataract
- Retinal detachment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2038 (estimated)
- Study completionMay 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Responsible party
- Sponsor
- Investigators
- Ramin TADAYONI, Pr, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849974
- Sponsor's protocol ID
- P22-03
- Acronym
- MyoCo1000
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Cohort of 1000 Patients With Severe Myopia
- ClinicalTrials.gov ID
- NCT05849974
- Acronym / sponsor ID
- MyoCo1000 / P22-03
- Conditions
- Myopia, Severe
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2038 (estimated)
- Study completion
- May 2038 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Hight Myopa | Experimental | Other: Structural and fonctional phynotypingLarge Cohort of patients with hight Myopa |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 6 years
- Severe myopia in at least one eye, defined as
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural and fonctional phynotypingThe 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 | Other | Hight Myopa |
Primary outcome
Visual acuity
Time frame: 10 years
Using the ETDRS and the near vision scale (decimal scales converted to logMAR)
Refraction measures
Time frame: 10 years
Measure will be performed in diopter
Lens opacity
Time frame: 10 years
Measure will be performed in pixel units
Intraocular pressure and pachymetry
Time frame: 10 years
These measurements are respectively carried out in mmHg and in μm
Retinal sensitivity and fixation stability
Time frame: 10 years
Respectively Performed in decibels and by microperimetry
Central visual field deficits
Time frame: 10 years
by automatic perimetry in decibels
Axial length
Time frame: 10 years
Will be performed in mm
Quantitative data
Time frame: 10 years
On optical coherence tomography (OCT) and OCT-Angiography
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...).
Area of Rétinal atrophy
Time frame: 10 years
In autofluorescence (in mm²)
Characterization of the type of staphyloma
Time frame: 10 years
staphyloma classification
Vitreous status
Time frame: 10 years
Liquefaction, stage of posterior vitreous detachment
Excavation of the optic nerve and area
Time frame: 10 years
In mm² of peripapillary atrophy on color and autofluorescence images
Anterior segment status
Time frame: 10 years
Chamber measurement, corneal curvature (in mm)
2 secondary outcomes
Macular ophthalmologic complications
Time frame: 10 years
Non-macular ophthalmologic complications
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramin TADAYONI, Pr principal investigator
Hôpital Fondation Adolphe de Rothschild
Questions about this trial
What is this clinical trial studying?
A study testing Structural and fonctional phynotyping in people with Myopia, Severe, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (+331 40 02 11 26, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 10 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.