Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
- Conditions
- Traumatic Cataract
- Registration Number
- NCT07087275
- Lead Sponsor
- Jin Yang
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Acuity From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) 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 (retrospective) measured by IOLMaster700
Corneal Astigmatism From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) Measured by IOLMaster700 and Pentacam
- Secondary Outcome Measures
Name Time Method Binocular Function From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) Binocular fusion and stereopsis will be assessed using standard clinical tools such as Worth 4-dot test and Randot stereoacuity test.
Intraocular Pressure (IOP) From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) IOP 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 (retrospective) Incidence of complications such as secondary glaucoma, visual axis opacification, retinal detachment, or IOL decentration will be recorded.
Intraocular Lens (IOL) Position From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) 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 (retrospective) 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.
Lens Thickness (LT) From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) Lens thickness (LT) will be measured using optical biometry and recorded in millimeters (mm).
White-to-White Corneal Diameter (WTW) From surgery up to 10 years postoperatively, depending on available follow-up duration (retrospective) 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 (retrospective) Keratometric values will be measured using optical biometry and recorded in diopters (D).
Trial Locations
- Locations (1)
Eye and ENT hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Eye and ENT hospital of Fudan University🇨🇳Shanghai, Shanghai, China