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

Jin Yang

Status: Active, not recruiting

Conditions: Traumatic Cataract

Study type: Observational

Funder types: Other

Identifiers

NCT07087275

Traumatic Cataract-FDU-2010

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

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

Trial design

600 participants in 1 patient group

Traumatic cataract

Description:

Traumatic cataract