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Recruiting NCT07070037

Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery

— Observational Congenital Cataract Pediatric Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Congenital Cataract, Pediatric Cataract. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study

Overview

This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.

Primary outcome measures

  • Visual Acuity [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • axial length [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Refractive Error [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
Secondary outcome measures (9)
  • IOP [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Corneal Curvature (K1 and K2) by Pentacam [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Stereopsis [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • white to white [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • anterior chamber depth [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Complications [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Central Corneal Thickness (CCT) [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Corneal Astigmatism Magnitude [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]
  • Binocular Fusion Assessment [Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Eye and ENT hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07070037 · Congenital Cataract-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗