Five-year vision and prescription outcomes after infant congenital cataract surgery
Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07070037 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Eye and ENT hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xuanqiao Lin
- Email: 1532483480@qq.com
- Phone: +8615088920668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.