- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803097
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation (capsular)
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhejiang
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Wenzhou, Zhejiang, China, 325027
- Ophthalmology and Optometry Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCOA
Time Frame: 20.74 ± 7.89 months
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A comparison of posterior capsular opening areas at the corresponding time points
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20.74 ± 7.89 months
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VATA
Time Frame: 20.74 ± 7.89 months
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A comparison of visual axis transparent areas at the corresponding time points
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20.74 ± 7.89 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
axial length growth
Time Frame: 20.74 ± 7.89 months
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The growth of axial length at the corresponding time points
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20.74 ± 7.89 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cataract- fuyana
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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