Customized bifocal plus defocus lenses to slow myopic shift after congenital cataract surgery
Official title: Investigation of Guangke Lenses' Efficacy in Delaying Myopia Onset/Progression in Postoperative Congenital Cataract Children
Run by Eye & ENT Hospital of Fudan University · NCT07778797 · Data updated 2026-11-12
This study tests whether individually tailored bifocal plus defocus glasses can slow myopic progression in children aged 4–12 who had bilateral congenital cataract surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 12 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 6, 2025 |
| Main results expected | August 6, 2028 |
| Study ends | August 6, 2030 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT07778797 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4–12 with bilateral congenital cataracts who recently had bilateral cataract extraction with IOL and can attend regular eye exams.
✕Probably not a fit
Children who do not show myopic progression or who have other ocular issues may not benefit from the lenses.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children who recently had bilateral congenital cataract extraction with IOL will wear specially designed bifocal plus defocus spectacles. Refraction and eye length will be tracked over time to see if the glasses slow the progression of myopia. The trial compares conventional bifocals with the customized lenses to determine any difference in myopic change after surgery. Regular ophthalmic exams, including refraction and axial length measurements, are required. The study is led by the Eye & ENT Hospital of Fudan University in Shanghai.
Why it matters
Potential benefit: If successful, the intervention could reduce the rate of myopic progression after congenital cataract surgery and improve long-term visual outcomes.
How similar studies have gone: Prior work suggests myopia control strategies can slow progression in children, but this specific customized bifocal plus defocus approach in post-surgical congenital cataract patients is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jin Yang, Dr.
- Email: jin_er76@hotmail.com
- Phone: 021-64377134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.