Study design
MYOPIA
The study was a prospective controlled observational study carried out in a paediatric ophthalmology clinic setting. The clinic has a reputation for myopia control and participants were highly motivated to pursue treatment, but often attended the clinic because of a preference for a specific intervention and therefore random allocation to study groups was not possible. Measurements of visual acuity (VA), cycloplegic autorefraction spherical equivalent refraction (SER), and axial length (AL) were taken by masked observers following a fixed protocol.Potential participants underwent a full ophthalmological assessment including symptoms and history, presenting VA with pre-study spectacles, orthoptic testing, refraction (including cycloplegic autorefraction), and dilated fundoscopy. Suitable participants (see below) were provided with information on three options for myopia control: 0.01% atropine, DIMS spectacles, or combined 0.01% atropine+DIMS. These options were discussed with patients, parents, and clinicians (PN, AL) and participants and their parents were free to choose their preferred option, or to continue in single vision spectacles. Some families were hesitant to undertake a long-term pharmacological or novel optical treatment and therefore opted not to undertake myopia control at that time and instead to join the control group and wear single vision spectacles.For all participants, written informed consent was obtained from parents/guardians. Participants were provided with their interventions and follow-up arranged after 3, 6, and 12 months. The outcome variables were assessed at each follow-up. The importance of attendance at follow-up was stressed to all participants, and telephone reminders were used together with rebooking of missed appointments to encourage attendance.The study received approval from the Ethics Committee of the University of Milan and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.