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

NCT ID: NCT07087275

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-01

Study Completion Date

2030-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traumatic cataract

Traumatic cataract

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Eye Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Jin Yang

OTHER

Sponsor Role lead

Responsible Party

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Jin Yang

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Traumatic Cataract-FDU-2010

Identifier Type: -

Identifier Source: org_study_id

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