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CompletedNCT04803097capsularUpdated Mar 17, 2021

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
6 Months to 96 Months
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Capsular Contracture, Implant
  • Pediatric Cataract

Keywords

  • capsular outcome
  • pediatric cataract
  • posterior capsulorhexis
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In context

Lead sponsor

Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 96 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. PCOA

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

    Time frame: 20.74 ± 7.89 months

  2. VATA

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

    Time frame: 20.74 ± 7.89 months

Secondary outcomes

  1. axial length growth

    The growth of axial length at the corresponding time points

    Time frame: 20.74 ± 7.89 months

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Study locations

1 site
  • Ophthalmology and Optometry Hospital
    Wenzhou, Zhejiang 325027, China
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References and documents

Publications

  • 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. PubMed 26537991 ↗
  • 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. PubMed 26962807 ↗
  • 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. PubMed 35463896 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04803097
Lead sponsor
Yune Zhao
Responsible party
Yune Zhao (Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University) — Sponsor-investigator
First posted
Mar 17, 2021
Start date
Jun 1, 2016
Primary completion
Jun 1, 2019
Completion
Jan 1, 2020
Last update
Mar 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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