NCT07087275|Active Not Recruiting
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Sponsor study identifier
observational
600
1 country
1
Study Start
June 1, 2010
Actual (reported)Primary Completion
June 1, 2020
Actual (reported)Study Completion
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2010
Actual (reported)June 1, 2020
Actual (reported)July 5, 2025
Actual (reported)July 25, 2025
Actual (reported)June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Visual Acuity
UDVA \& BCVA will be assessed using age-appropriate optotypes (e.g., Lea symbols, Snellen chart, or ETDRS chart) and recorded in logMAR units.
From surgery up to 10 years postoperatively, depending on available follow-up duration
Axial Length Development
Axial Length(mm) measured by IOLMaster700
From surgery up to 10 years postoperatively, depending on available follow-up duration
Corneal Astigmatism
Measured by Pentacam
From surgery up to 10 years postoperatively, depending on available follow-up duration
Corneal Astigmatism
Measured by IOLMaster700
From surgery up to 10 years postoperatively, depending on available follow-up duration
Binocular Function
From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Pressure (IOP)
From surgery up to 10 years postoperatively, depending on available follow-up duration
Postoperative Complications
From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Lens (IOL) Position
From surgery up to 10 years postoperatively, depending on available follow-up duration
Anterior Chamber Depth (ACD)
From surgery up to 10 years postoperatively, depending on available follow-up duration
Traumatic cataract
This study will enroll pediatric patients aged 0 to 16 years who were diagnosed with traumatic cataract and underwent cataract surgery at the Eye, Ear, Nose, and Throat Hospital of Fudan University, or the Eye Hospital of Wenzhou Medical University, or the First Affiliated Hospital of Nanjing Medical University. Eligible patients may have experienced either blunt or penetrating ocular trauma. Both unilateral and bilateral cases are included. All participants must be able to complete regular follow-up evaluations for at least 5 years after surgery. The study population reflects a broad spectrum of post-traumatic cataract severity and treatment modalities, representing real-world clinical settings.
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
First Submitted
July 5, 2025
First Posted
July 25, 2025
Study Start
June 1, 2010
Actual (reported)Primary Completion
June 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 13, 2026
Record last verified: 2025-12
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