| NCT ID | NCT07778797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Congenital Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2028-08-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-06 with a primary completion date of 2028-08-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate whether individually customized bifocal + defocus spectacles can slow myopic shift in children after congenital cataract surgery.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07778797 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Congenital Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07778797 currently recruiting?
Yes, NCT07778797 is actively recruiting participants. Contact the research team at jin_er76@hotmail.com for enrollment information.
Where is the NCT07778797 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07778797 clinical trial?
NCT07778797 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 50 participants.