An observational study in Capsular Contracture, Implant and Pediatric Cataract, sponsored by Yune Zhao. Completed at 1 site in China. Open to participants aged 6 Months to 96 Months. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Yune Zhao · Observational
Lens capsular often changes after pediatric cataract surgery,causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.
To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.
Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Patients (age:0.5\~8.0 years)with congenital cataract
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Children (age 0.5\~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.
Exclusion Criteria:
Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.
Children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China) between 2016 and 2019 were included in the study. Every surgery included posterior capsulorhexis or capsulotomy and anterior vitrectomy. Patients accept slit-lamp-adapted anterior segmental photography at 1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively.
PCOA
A comparison of posterior capsular opening areas at the corresponding time points
Time frame: 20.74 ± 7.89 months
VATA
A comparison of visual axis transparent areas at the corresponding time points
Time frame: 20.74 ± 7.89 months
axial length growth
The growth of axial length at the corresponding time points
Time frame: 20.74 ± 7.89 months
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Implant Capsular Contracture
Yune Zhao