Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

Pediatric Cataract Clinical Trial

— capsular  

Official title:

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803097
• Other study ID #: cataract- fuyana
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 96 Months

Eligibility

Inclusion Criteria:

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.

Related Conditions & MeSH terms

• Capsular Contracture, Implant
• Cataract
• Contracture
• Implant Capsular Contracture
• Pediatric Cataract

Locations

Country	Name	City	State
China	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Yune Zhao

Country where clinical trial is conducted

China, 

References & Publications (2)

Lin H, Tan X, Lin Z, Chen J, Luo L, Wu X, Long E, Chen W, Liu Y. Capsular Outcomes Differ with Capsulorhexis Sizes after Pediatric Cataract Surgery: A Randomized Controlled Trial. Sci Rep. 2015 Nov 5;5:16227. doi: 10.1038/srep16227. — View Citation

Tan X, Lin H, Lin Z, Chen J, Tang X, Luo L, Chen W, Liu Y. Capsular Outcomes After Pediatric Cataract Surgery Without Intraocular Lens Implantation: Qualitative Classification and Quantitative Measurement. Medicine (Baltimore). 2016 Mar;95(10):e2993. doi: 10.1097/MD.0000000000002993. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCOA	A comparison of posterior capsular opening areas at the corresponding time points	20.74 ± 7.89 months
Primary	VATA	A comparison of visual axis transparent areas at the corresponding time points	20.74 ± 7.89 months
Secondary	axial length growth	The growth of axial length at the corresponding time points	20.74 ± 7.89 months