An interventional study of Novel plano spectacle lenses in Myopic Children, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Active, not recruiting at 1 site in China. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
Device: Novel plano spectacle lenses
Objectively measuring outdoor time by smart bracelet.
Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
One-year cumulative myopia incidence in either eye
One-year cumulative myopia incidence in either eye
Time frame: From enrollment to the end of intervention for one year
Changes of spherical equivalent under cycloplegia
Changes of spherical equivalent under cycloplegia
Time frame: From enrollment to the end of intervention for one year
Changes of axial length
Changes of axial length
Time frame: From enrollment to the end of intervention for one year
Changes of choroidal thickness
Changes of choroidal thickness
Time frame: From enrollment to the end of intervention for one year
Changes of unaided distance visual acuity
Changes of unaided distance visual acuity
Time frame: From enrollment to the end of intervention for one year
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
Time frame: From enrollment to the end of intervention for one year
Changes of accommodation function
Changes of accommodation function
Time frame: From enrollment to the end of intervention for one year
Wearing time recorded in the questionnaire and smart frame
Wearing time recorded in the questionnaire and smart frame
Time frame: From enrollment to the end of intervention for one year
Objective outdoor time recorded with smart bracelet
Objective outdoor time recorded with smart bracelet
Time frame: From enrollment to the end of intervention for one year
Incidence and severity of adverse events (AEs) related to study intervention
Incidence and severity of adverse events (AEs) related to study intervention
Time frame: From enrollment to the end of intervention for one year
Monocular best-corrected visual acuity (BCVA)
Monocular best-corrected visual acuity (BCVA)
Time frame: From enrollment to the end of intervention for one year
Assessment of symptoms, complaints related to the study intervention, as reported by participants.
Assessment of symptoms, complaints related to the study intervention, as reported by participants.
Time frame: From enrollment to the end of intervention for one year
Plan to share: No
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Eye Disease Prevention and Treatment Center