About this trial
Study to determine the efficacy of alpha-2 adrenergic drugs (brimonidine) in the prevention of myopia progression. Given that the drugs used so far have limited efficacy and side effects (loss of near vision, photophobia), it may be an interesting contribution to such treatment at low cost, and to avoid the expense of managing the complications of myopia that develop throughout life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 6 to ≤ 14 years
Patients who, after having received information about the design, the purposes of the study, the possible risks that may arise from it and that at any time they may refuse to cooperate, give written consent to participate in the study (the patient older than 12 years and the legal representative)
Myopia ≥ -1. 50 Diopters of spherical equivalent, ranging from -1.50 to -5.50 D
Astigmatism with a cylinder power ≤ -1.50 Diopters
Disqualifiers
Presence of any other ocular pathology (other than myopia)
History of allergy to the medications and excipients used in the study
History of previous therapy for myopia using eye drops, contact lenses or multifocal or bifocal glasses
Amblyopia (2 or more lines of difference in visual acuity between both eyes, on logMAR scale, with optical correction)
Trial design
Single group
Treatments tested in this trial
Treatment with brimonidine eye drops 0.025%
DrugTreatment with brimonidine eye drops 0.025%, instilled once a day at night, with simultaneous occlusion of the lower lacrimal punctum to avoid its systemic absorption, for 2 years.
Treatment groups
Trial outcomes
Primary outcomes
Effect of brimonidine eye drops 0.025% on myopia progression in children aged 6 to 14 years
Progression of myopia (change in spherical equivalent of refractive error) measured every 6 months (Auto-refractometry and Subjective refraction)
Secondary outcomes
Progression of various ocular biometric variables in the children of the treated and control groups,
Myopia progression by measuring every 6 months: change in axial eye length
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: visual acuity
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: pupillometry/accommodation
Progression of various ocular biometric variables in the children of the treated and control groups
Description: Myopia progression by measuring every 6 months: corneal topography
Sponsors and contacts
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