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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07087275

Enrollment

600

Registered

2025-07-25

Start date

2010-06-01

Completion date

2030-06-01

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Cataract

Keywords

Traumatic Cataract, Cataract Surgery, Pediatric Cataract

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Acuity	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.
Axial Length Development	From surgery up to 10 years postoperatively, depending on available follow-up duration	Axial Length(mm) measured by IOLMaster700
Corneal Astigmatism	From surgery up to 10 years postoperatively, depending on available follow-up duration	Measured by Pentacam

Secondary

Measure	Time frame	Description
Intraocular Lens (IOL) Position	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.
Anterior Chamber Depth (ACD)	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.
Binocular Function	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.
White-to-White Corneal Diameter (WTW)	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).
Keratometry	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).
Lens Thickness (LT)	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).
Intraocular Pressure (IOP)	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.
Postoperative Complications	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.

Countries

China

Outcome results