Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:
• Children aged 6 to ≤ 11 years with bilateral myopia
• Onset of myopia ≥ 4 years of age
• History of progression
• SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
• Intraocular pressure \< 21 mm Hg in each eye
• Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye
Locations
Other Locations
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
OLVG, locatie Oost
RECRUITING
Amsterdam
Ophthalmologistenpraktijk Delfland
RECRUITING
Delft
Reinier de Graaf Gasthuis
RECRUITING
Delft
Deventer Ziekenhuis
RECRUITING
Deventer
Albert Schweitzer ziekenhuis
RECRUITING
Dordrecht
Bergman Clinics - Ede
RECRUITING
Ede
Admiraal de Ruyter Ziekenhuis
RECRUITING
Goes
Frisius MC
RECRUITING
Heerenveen
Oogcentrum Noordholland
RECRUITING
Heerhugowaard
Leiden University Medical Center
RECRUITING
Leiden
Bergman Clinics - Lelystad
RECRUITING
Lelystad
Maastricht UMC+
RECRUITING
Maastricht
St. Antonius
RECRUITING
Nieuwegein
Radboudumc
RECRUITING
Nijmegen
Erasmus Medical Center
RECRUITING
Rotterdam
Haga Ziekenhuis
RECRUITING
The Hague
Oogkliniek Den Haag
RECRUITING
The Hague
Ziekenhuis Rivierenland Tiel
RECRUITING
Tiel
Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
Contact Information
Primary
Jan Roelof Polling, Dr.
j.polling@erasmusmc.nl
+31628449254
Backup
Trialbureau Oogheelkunde
research.oogheelkunde@erasmusmc.nl
+31107039740
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 550
Treatments
Active_comparator: Low dose atropine
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Active_comparator: High dose atropine
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development