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OpenTrials
Completed

NCT Number: NCT04803097

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

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.

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Key information

Conditions

Capsular Contracture, Implant Foreign-Body Reaction Implant Capsular Contracture Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Cataract Postoperative Complications Prosthesis Failure

Age range

6 month–96 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, 325027, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PCOA

    Time frame: 20.74 ± 7.89 months

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

  2. VATA

    Time frame: 20.74 ± 7.89 months

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

Secondary outcomes

  1. axial length growth

    Time frame: 20.74 ± 7.89 months

    The growth of axial length at the corresponding time points

Sponsors and collaborators

Lead sponsor

Yune Zhao

Other

Registry information

Official study title

Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens

Acronym: capsular

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 17, 2021
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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