Health TrialsbyHealthPanel

Large Cohort of 1000 Patients With Severe Myopia

ConditionMyopia, Severe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Structural and fonctional phynotyping

    Other intervention

    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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Hight MyopaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual acuity

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

Time frame
10 years
2

Refraction measures

Measure will be performed in diopter

Time frame
10 years
3

Lens opacity

Measure will be performed in pixel units

Time frame
10 years
4

Intraocular pressure and pachymetry

These measurements are respectively carried out in mmHg and in μm

Time frame
10 years

Secondary outcomes

1

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

Time frame
10 years
2

Non-macular ophthalmologic complications

* Glaucoma optic Neuropathy * Cataract * Retinal detachment

Time frame
10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: