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NCT Number: NCT07087275

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Traumatic Cataract

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Visual Acuity

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

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

  2. Axial Length Development

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

    Axial Length(mm) measured by IOLMaster700

  3. Corneal Astigmatism

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

    Measured by Pentacam

  4. Corneal Astigmatism

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

    Measured by IOLMaster700

Secondary outcomes

  1. Binocular Function

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

    Binocular fusion and stereopsis will be assessed using standard clinical tools such as Worth 4-dot test and Randot stereoacuity test.

  2. Intraocular Pressure (IOP)

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

    IOP(mmHg) will be monitored using non-contact or Goldmann applanation tonometry to detect postoperative ocular hypertension or glaucoma.

  3. Postoperative Complications

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

    Incidence of complications such as secondary glaucoma, visual axis opacification, retinal detachment, or IOL decentration will be recorded.

  4. Intraocular Lens (IOL) Position

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

    IOL centration and tilt will be evaluated by slit-lamp exam or anterior segment OCT.

  5. Anterior Chamber Depth (ACD)

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

    Anterior chamber depth (ACD) will be measured using optical biometry and recorded in millimeters (mm) as the distance from the corneal endothelium to the anterior lens surface.

  6. Lens Thickness (LT)

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

    Lens thickness (LT) will be measured using optical biometry and recorded in millimeters (mm).

  7. White-to-White Corneal Diameter (WTW)

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

    WTW corneal diameter will be measured using optical biometry and recorded in millimeters (mm).

  8. Keratometry

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

    Keratometric values will be measured using optical biometry and recorded in diopters (D).

Sponsors and collaborators

Lead sponsor

Jin Yang

Other

Collaborators

  • The Eye Hospital of Wenzhou Medical University
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2030
First posted
Jul 25, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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