Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children

NCT07087275 | Active Not Recruiting

• 1 other identifier: Traumatic Cataract-FDU-2010
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective multicenter observational study aims to evaluate long-term visual and ocular biometric outcomes in pediatric patients aged 0-16 years who were diagnosed with traumatic cataract and underwent cataract extraction surgery. Medical records of eligible patients with at least 5 to 10 years of postoperative follow-up will be reviewed. Key outcome measures include best-corrected visual acuity (BCVA), axial length, corneal astigmatism, intraocular pressure (IOP), binocular function (fusion and stereopsis), intraocular lens (IOL) position, and postoperative complications. The study seeks to provide insight into long-term visual rehabilitation and prognostic indicators following pediatric traumatic cataract surgery.

Conditions

Traumatic Cataract

Keywords

Traumatic Cataract; Cataract Surgery; Pediatric Cataract

Outcome Measures

Primary Outcomes (4)

• Visual Acuity

  UDVA \& BCVA will be assessed using age-appropriate optotypes (e.g., Lea symbols, Snellen chart, or ETDRS chart) and recorded in logMAR units.

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Axial Length Development

  Axial Length(mm) measured by IOLMaster700

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Corneal Astigmatism

  Measured by Pentacam

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Corneal Astigmatism

  Measured by IOLMaster700

  From surgery up to 10 years postoperatively, depending on available follow-up duration

Secondary Outcomes (8)

• Binocular Function

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Intraocular Pressure (IOP)

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Postoperative Complications

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Intraocular Lens (IOL) Position

  From surgery up to 10 years postoperatively, depending on available follow-up duration

• Anterior Chamber Depth (ACD)

  From surgery up to 10 years postoperatively, depending on available follow-up duration

Study Arms (1)

Traumatic cataract

Traumatic cataract

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll pediatric patients aged 0 to 16 years who were diagnosed with traumatic cataract and underwent cataract surgery at the Eye, Ear, Nose, and Throat Hospital of Fudan University, or the Eye Hospital of Wenzhou Medical University, or the First Affiliated Hospital of Nanjing Medical University. Eligible patients may have experienced either blunt or penetrating ocular trauma. Both unilateral and bilateral cases are included. All participants must be able to complete regular follow-up evaluations for at least 5 years after surgery. The study population reflects a broad spectrum of post-traumatic cataract severity and treatment modalities, representing real-world clinical settings.

You may qualify if:

• Aged 0 to 16 years at the time of trauma-related cataract diagnosis
• Diagnosed with traumatic cataract (due to blunt or penetrating ocular trauma)
• Underwent cataract extraction surgery with or without intraocular lens (IOL) implantation
• Able to attend regular follow-up assessments for at least 5 years postoperatively
• Written informed consent obtained from a parent or legal guardian

You may not qualify if:

• Congenital or developmental cataract
• Pre-existing ocular diseases unrelated to trauma (e.g., congenital glaucoma, retinal dystrophies)
• Severe posterior segment damage precluding reliable visual outcome evaluation (e.g., endophthalmitis, choroidal rupture involving the macula)
• Systemic or neurological disorders that affect vision or compliance with follow-up (e.g., cerebral palsy, intellectual disability)
• Previous intraocular surgery in the affected eye unrelated to the trauma

Sponsors & Collaborators

• The Eye Hospital of Wenzhou Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Jin Yang: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

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: July 5, 2025
• First Posted: July 25, 2025
• Study Start: June 1, 2010
• Primary Completion: June 1, 2020
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)