Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT07176949
The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.
Interested in participating?
Request Info3 year–6 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use 0.01% atropine eyedrops nightly for myopia control.
Participants will use 0.05% atropine eyedrops nightly for myopia control.
These are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called "myopic defocus." Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse.
Time frame: 2 year
Measured by an auto-refractometer
Time frame: 2 years
Measured by an IOL-Master
Time frame: 2 years
Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.
Time frame: 2 years
Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.
Time frame: 2 years
Measured by SS-OCT
Time frame: 2 years
Best corrected visual acuity
Time frame: 2 years
Intraocular pressure
Time frame: 2 years
Amplitude of Accommodation
Time frame: 2 years
Using Titmus Fly Test
Time frame: 2 years
Tear Film Break-Up Time
Time frame: 2 years
Measured by Pentacam
Time frame: 2 years
Measured by SS-OCTA
Time frame: 2 years
Daily wearing duration, wearing habits and patterns, frequency of eye drops use.
Time frame: 2 years
Incidence of glare, diplopia, blurred vision, photophobia, etc.
Contact information is provided by the study sponsor or research team.
Shanghai Eye Disease Prevention and Treatment Center
Other
Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai
Acronym: EOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06995911
Eye Diseases, Myopia
Shanghai, China
View Trial DetailsNCT07316998
Eye Diseases, Myopia
Paris, France
View Trial DetailsNCT07567040
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial DetailsNCT07698977
Eye Diseases, Myopia
Budapest, Hungary
View Trial Details