Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
Condition(s) studied
Investigational drug(s) / intervention(s)
0.05% atropine eye drops: One drop of 0.05% atropine in each eye once a day before bedtime
0.025% atropine eye drops: One drop of 0.025% atropine in each eye once a day before bedtime
placebo eye drops: One drop of placebo in each eye once a day before bedtime
Study summary
Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors.
Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.
Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized.
Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age.
The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%.
Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents.
MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.
Eligibility
Primary outcome measure(s)
- Mean annual rate of progression of myopia — 24 months
The primary outcome measure evaluates the efficacy of atropine in slowing myopia progression in children and adolescents. The mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction over 24 months.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Centre Mother Teresa (UHCT), Paediatric Department | Tirana | Albania | Recruiting |
| Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII | Bari | Italy | Recruiting |
| Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan | Milan | Italy | Recruiting |
| Azienda Ospedale Università Padova | Padua | Italy | Not Yet Recruiting |
| Children's Memorial Health Institute, Department of Ophthalmology | Warsaw | Poland | Recruiting |
| Hospital Universitario Parc Taulí | Barcelona | Spain | Recruiting |
| Hospital Puerta del Mar (INIBICA) | Cadiz | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital | Belfast | United Kingdom | Recruiting |
| School of Optometry, Aston University | Birmingham | United Kingdom | Recruiting |
| R&D, Moorfields Eye Hospital | London | United Kingdom | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07028827 on ClinicalTrials.gov ↗ ← All trials in Italy