Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

NCT04803097 | Completed

• 1 other identifier: cataract- fuyana
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Capsular Contracture, Implant; Pediatric Cataract

Keywords

capsular outcome; pediatric cataract; posterior capsulorhexis

Outcome Measures

Primary Outcomes (2)

• PCOA

  A comparison of posterior capsular opening areas at the corresponding time points

  20.74 ± 7.89 months

• VATA

  A comparison of visual axis transparent areas at the corresponding time points

  20.74 ± 7.89 months

Secondary Outcomes (1)

• axial length growth

  20.74 ± 7.89 months

Study Arms (1)

pediatric cataract group

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.

Eligibility Criteria

• Age: 6 Months - 96 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients （age：0.5\~8.0 years）with congenital cataract

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yune Zhao: lead

Study Sites (1)

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

Location

Related Publications (3)

• 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.

  PMID: 26537991 BACKGROUND

• 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.

  PMID: 26962807 BACKGROUND

• Fu Y, Wang D, Ding X, Chang P, Zhao Y, Hu M, Li Z, Zhao YE. Posterior Capsular Outcomes of Pediatric Cataract Surgery With In-The-Bag Intraocular Lens Implantation. Front Pediatr. 2022 Apr 8;10:827084. doi: 10.3389/fped.2022.827084. eCollection 2022.

  PMID: 35463896 DERIVED

MeSH Terms

Conditions

Implant Capsular Contracture

Condition Hierarchy (Ancestors)

Foreign-Body Reaction; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prosthesis Failure; Postoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

CN (1)