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

NCT07070037 | Recruiting

• 1 other identifier: Congenital Cataract-2025-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Cataract; Pediatric Cataract

Keywords

Congenital Cataract; Pediatric Cataract Surgery; Visual Function; Stereopsis; Amblyopia; Long-term Outcomes

Outcome Measures

Primary Outcomes (3)

• Visual Acuity

  UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

• axial length

  AL

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

• Refractive Error

  Refractive Error

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

Secondary Outcomes (9)

• IOP

  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

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

• Stereopsis

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

• white to white

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

• anterior chamber depth

  Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

Study Arms (1)

congenital cataract

congenital cataract

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll pediatric patients diagnosed with congenital cataract who underwent cataract extraction with or without intraocular lens (IOL) implantation. Participants must be able to complete regular postoperative follow-up assessments from the time of surgery up to 5 years. Both unilateral and bilateral cases are eligible. The study population is recruited from multiple tertiary eye centers in China.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Yang

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xuanqiao Lin

CONTACT

+8615088920668; 1532483480@qq.com

Lei Cai

CONTACT

1532483480@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 17, 2025
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)