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Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation (capsular)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04803097
Recruitment Status : Completed
First Posted : March 17, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Study Description
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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.

Condition or disease
Capsular Contracture, Implant Pediatric Cataract

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.
Study Design
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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. axial length growth [ Time Frame: 20.74 ± 7.89 months ]
    The growth of axial length at the corresponding time points


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients （age：0.5~8.0 years）with congenital cataract
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803097


Locations
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China, Zhejiang
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Yune Zhao
More Information
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Publications:

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Responsible Party: Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04803097    
Other Study ID Numbers: cataract- fuyana
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yune Zhao, Wenzhou Medical University:
capsular outcome
pediatric cataract
posterior capsulorhexis
Additional relevant MeSH terms:
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Contracture
Cataract
Implant Capsular Contracture
Lens Diseases
Eye Diseases
Joint Diseases
Musculoskeletal Diseases
 Muscular Diseases
Foreign-Body Reaction
Inflammation
Pathologic Processes
Prosthesis Failure
Postoperative Complications