MYOPIA IN PEDIATRIC POPULATION
Conditions
Interventions
Trade Name: COLIRCUSÍ ATROPINA 10 mg/ml colirio en solución
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: ATROPINE SULFATE
CAS Number: 55-48-1
Current Sponsor code: pr1
Concentration u
Sponsors
NOEMI GUEMES VILLAHOZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between 4-16 years of age. Informed consent signed by parents or guardians in all patients and patients between 12 and 16 years of age. Refractive defect: myopia greater than -1.00 diopters (D). Progression of myopia of at least -0.50 D in the last 12 months Astigmatism of 2 D or less and anisometropia of 1.50 D or less Monocular visual acuity (VA) best corrected of 0.2 logMAR (6/9) or better Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Under 4 years old and over 16 years old Strabismus and binocular vision abnormalities Fundus with alterations that the investigator considers exclusive to participate in the study. Ocular pathology of the anterior segment (opacity of media such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision. Previous eye surgery amblyopia systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation) Previous treatments for the control of myopia, including orthokeratology, rigid contact lenses, bifocal soft contact lenses or for the control of myopia, bifocal and multifocal ophthalmic lenses in the 3 months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To know the efficacy and safety of the combined use of 0.01% diluted atropine eye drops and DIMS technology ophthalmic lenses in the control of myopia progression in the pediatric population;Secondary Objective: Know the tolerance of ophthalmic lenses with DIMS technology in myopic pediatric population Evaluate and measure the effect on the refractive state and axial length in each treatment group;Primary end point(s): Refractive defect after cycloplegia with 1% cyclopentolate 3 drops 10 minutes apart. Assessment after 30 minutes.;Timepoint(s) of evaluation of this end point: primary end point will be evaluate every 6 month for 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Axial length in millimeters Choroidal and retinal thickness measured in Optical Coherence Tomography (OCT) in ?m Intraocular pressure in mmHg;Timepoint(s) of evaluation of this end point: 3, 6 ,12 ,18, 24 months | — |
Countries
Spain
Contacts
Public ContactSERVICIO DE OFTALMOLOGIA
HOSPITAL CLINICO SAN CARLOS
Outcome results
None listed