Clinical trial Recruiting at 1 site Observational Ages Any age to 18

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.

More Congenital Cataract trials

Quick facts

Study typeObservational
AgesAny age to 18 Years
SexAll
Enrollment400 (estimated)
SponsorEye & ENT Hospital of Fudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 1, 2014
Main results expectedDecember 31, 2030
Study endsDecember 31, 2035
Registry record updatedAugust 20, 2025
Trial IDNCT07070037 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.