Could a lens design curb myopia after childhood cataract surgery?
NCT ID NCT07778797
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial tests whether individually customized bifocal spectacles with a peripheral defocus design can slow the progression of myopia (nearsightedness) in children aged 4 to 12 who have had surgery for congenital cataracts. Participants will be randomly assigned to wear either these specialized lenses or conventional bifocal glasses. The study will measure changes in eye length and refractive error over time to see if the defocus design helps control myopic shift.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Individually customized bifocal spectacles with peripheral defocus design
- What this could lead to
- If effective, these specialized glasses could offer a non-invasive way to control myopia in children after cataract surgery, potentially reducing the need for stronger prescriptions and protecting long-term vision.
- What could go wrong
- This is a relatively small, early-stage trial, and results may not apply to all children. The lenses might not significantly slow myopia progression, and there is a risk of side effects like discomfort or adaptation issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Aged 4 to 12 years (inclusive) at the time of enrollment. Diagnosed with bilateral congenital cataracts. Has undergone bilateral cataract extraction with intraocular lens (IOL) implantation. Time since cataract surgery is between 1 to 6 months (inclusive) at the time of enrollment. Able to undergo regular ophthalmic examinations (including refraction, axial length measurement, and intraocular pressure assessment). Parent(s) or legal guardian(s) are willing and able to provide written informed consent. Exclusion Criteria: Presence of any systemic disease (e.g., metabolic disorders, autoimmune diseases, genetic syndromes, etc.). Presence of any ocular disease other than congenital cataracts (e.g., glaucoma, uveitis, retinal disorders, corneal diseases, strabismus, amblyopia, etc.). Previous or current use of myopia control treatments, including but not limited to atropine eye drops, orthokeratology (Ortho-K) lenses, or other myopia control spectacle lenses. History of ocular trauma or intraocular surgery other than cataract extraction and IOL implantation. Known allergy or hypersensitivity to any materials or components used in the study lenses. Inability to comply with the study protocol or complete scheduled follow-up visits. Participation in another interventional clinical trial within the past 30 days.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Eye & ENT Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200031, China
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