Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

NCT ID: NCT04803097

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Capsular Contracture, Implant Pediatric Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intervention Type DIAGNOSTIC_TEST

We took slit-lamp-adapted anterior segmental photography from pediatric cataract eyes at baseline,1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively.

Interventions

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We took slit-lamp-adapted anterior segmental photography from pediatric cataract eyes at baseline,1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

96 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yune Zhao

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ophthalmology and Optometry Hospital

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26537991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26962807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35463896 (View on PubMed)

Other Identifiers

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cataract- fuyana

Identifier Type: -

Identifier Source: org_study_id

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