Five-year vision and prescription outcomes after infant congenital cataract surgery
Official title: Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study
Run by Eye & ENT Hospital of Fudan University · NCT07070037 · Data updated 2026-11-12
This project will see how vision and eye prescription change over five years in children who had congenital cataract surgery before age one.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2014 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2035 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07070037 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children diagnosed with congenital cataract who had cataract extraction before one year of age and whose legal guardian can provide consent and attend regular follow-up visits for at least five years are ideal candidates.
✕Probably not a fit
Patients with traumatic or acquired cataracts, significant ocular malformations, systemic syndromes affecting vision, or those unable to complete long-term follow-up are unlikely to gain useful information from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter observational project that follows children who underwent cataract extraction before their first birthday to document visual and refractive development over five years. Participants will attend regular follow-up visits with measurements including best-corrected visual acuity, stereopsis, refractive error, and axial length growth. Children with acquired or traumatic cataracts, major ocular malformations, systemic syndromes affecting vision, or prior secondary surgeries are excluded to keep outcomes specific to early congenital cataract intervention. The data will be used to identify long-term trends and prognostic indicators to improve postoperative care and counseling.
Why it matters
Potential benefit: If successful, the results could help clinicians predict long-term vision and refractive changes and optimize postoperative management for infants with congenital cataract.
How similar studies have gone: Previous cohort and single-center studies have reported variable long-term outcomes after early congenital cataract surgery, providing useful but sometimes inconsistent prognostic data and indicating a need for more multicenter prospective data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of congenital cataract * Underwent cataract extraction before 1 year of age * Available for regular follow-up for at least 5 years postoperatively * Written informed consent from legal guardian Exclusion Criteria: * Acquired cataract or traumatic origin * Associated ocular malformations (e.g., microphthalmia, coloboma) * Systemic syndromes affecting vision (e.g., Down syndrome) * History of secondary surgery affecting visual outcome
Where it's running
-
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Xuanqiao Lin
- Email: 1532483480@qq.com
- Phone: +8615088920668
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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.