Myopia
Conditions
Interventions
Product Name: atropine 0.01%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: ATROPINE SULFATE
CAS Number: 55-48-1
Concentr
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -- Children with myopia between -1 and -6 spherical diopters measured under cycloplegia with an automatic refractor. - Progressive myopia characterized by a minimal rate of progression of -0.75 diopters in the last 12 months - Age between 4 and 12 years old included at the time of signing the consent. - Negative urinary pregnancy test for women of childbearing age using an effective contraceptive method (oral, intravaginal or transdermal estroprogestogenic hormonal contraception or oral, subcutaneous, injectable or intrauterine device, or intrauterine hormonal device, occlusion sterilization of the fallopian tubes, sexual abstinence) - Consent to participate in the study signed by both parents of the child. - Subject affiliated to a social security health insurance scheme. Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Astigmatism = with 1.5 diopters - Anisometropy = with 2 diopters - Presence of an ocular surface or corneal pathology (recurrent keratalgia, keratoconus) - Presence of a pathology of the anterior segment (Iranian malformation, cataract) - Presence of a pathology of the posterior or retinal segment (dystrophies or acquired diseases) - Presence of an old or progressive inflammatory pathology (uveitis) - Presence of strabismus or disturbance of stereoscopic vision (Lang Test not seen) - Presence of amblyopia - Contraindication to the use of the investigational medicinal product and/or to the explorations provided for in the protocol - Hypersensitivity to atropine or any of the excipients of the eye drops present in the raw material - Impossibility of giving the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.) - Subjects treated with psychotropic drugs - Subjects with a psychiatric condition - Subject under the protection of justice - Subject under guardianship or curatorship - Pregnant and breastfeeding women -Women capable of procreation (from first menstruation to menopause) not using contraceptive methods. In the event of a first menstruation occurring during the subject's participation, a urinary pregnancy test will be performed and an effective method of contraception will be initiated (oral, intravaginal or transdermal estroprogestogenic hormonal contraception or oral, subcutaneous, injectable or progestin-only hormonal contraception or intrauterine device, or intrauterine hormonal device, fallopian tube occlusion sterilization, sexual abstinence)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of atropine eye drops at 0.01% (1 drop per day administered for 52 weeks) on the reduction of progressive myopia in children 4 to 12 years of age, compared to a control group (instillation of a placebo).;Timepoint(s) of evaluation of this end point: Week 52; Secondary Objective: - Evaluate the efficacy of atropine eye drops at 0.01% on the reduction of progressive myopia in children at 13, 26 and 39 weeks after starting treatment. - Evaluate biometric modifications (axial length, anterior chamber depth, lens thickness, corneal diameter, corneal curvature, macular thickness, choroidal thickness, ganglion fibre thickness, retinal vessel morphology) in relation to myopia and their modifications by treatment with 0.01% atropine; - Evaluate the tolerance of the administration of atropine in eye drops at 0.01%. - Evaluate patient compliance; - Study the possible prognostic factors responsible for limiting myopia: External and internal physical activities, Body Mass Index, Growth Correlation, Seasonality, Corneal Dystrophy. ; Primary end point(s): Degree of myopia measured in spherical diopters after cycloplegia with an automatic refractometer at 52 weeks of treatment in the Atropine 0.01% and Placebo treatment groups. The value of the refraction will be an average of 6 measurements. Studies have shown a small variation in intra-individual measurements depending on the used refractometers (Xiong, et al. 2017a). Two cycloplegia protocols are prescribed according to iris staining (Mackey, et al. 2011). The same cycloplegia protocol will be prescribed to a given patient for the duration of the study. For light irises (stages 1 to 6), cycloplegia with cyclopentolate or atropine will be prescribed. For dark irises (stage 7 to 9), atropine cyloplegia will be prescribed. The cyclopentolate cycloplegia protocol is as fol | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 13, 26, 39 et 52; Secondary end point(s): - Evolution of the degree of myopia measured in spherical diopters after cycloplegia with an automatic refractometer at 13, 26 and 39 weeks compared to the value at inclusion; - Evolution of biometric criteria measured at 13, 26, 39 and 52 weeks compared to the values at inclusion Axial length measurement in mm: Non-contact optical computer type Iolmaster, Zeiss* Anterior chamber depth in mm: Non-contact optical computer type Iolmaster, Zeiss* Lens thickness in mm: OCT Spectral Front segment domain Total macular thickness and choroidal thickness in µm, ganglion fibre thickness in µm: OCT Spectral Posterior segment domain Corneal diameter in mm, corneal curvature in mm, central corneal thickness in µm, keratometry (K1, K2 and Km in mm): Corneal topography - Adverse events reported at 13, 26, 39 and 52 weeks Pupil diameter measurement in mm (OPDscan, Topolyzer Vario) Accommodation: measurement at prisms of the amplitude of accommodation in diopters and the convergence point in near vision in cm Eye surface tolerance: Break-up time in seconds and Oxford score (0 to 5) Collection of potential serious adverse reactions - Quality of life measured at 13, 26, 39 and 52 weeks Photophobia, difficulty reading, accommodation, embarrassment induced by the pathology: Score on the questionnaire "Impact on quality of life - VFQ-25 adapted to ophthalmology". - Studies of confounding factors measured at 13, 26, 39 and 52 weeks Score on the standardized physical activity questionnaire (PAQ-Children) Weight in kg and patient height in cm - Compliance measured at 13, 26, 39 and 52 weeks Measureme | — |
Countries
France
Contacts
Public ContactEric DEMONSANT
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed