Outcome of Capsular After Pediatric Cataract Surgery With Primary Intraocular Lens Implantation

NCT ID: NCT04357249

Last Updated: 2020-04-22

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2020-08-01

Brief Summary

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The aim of this study is to evaluate the outcome of capsular in children with cataract, and to explore potential preoperative structural clues for postoperative glaucoma. The investigators included children with cataract planning to have cataract surgery in our institute. Exclusion criteria were: a history of ocular trauma, a history of intraocular surgery, preoperative glaucoma, steroid use before surgery, a history of maternal rubella syndrome, chronic anterior uveitis, persistent fetal vasculature, ocular anomalies associated with an increased risk of glaucoma, unable to complete examinations. The investigators recorded age at surgery, gender and relevant ocular and systemic histories. All patients underwent slit lamp biomicroscopy, slit lamp adapted anterior segment photography.All patients were examined at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, and two years after surgery. Patients were followed for two years or until the development of severe VAO requiring Nd: YAG laser capsulotomy, whichever came first. The examinations consisted of visual acuity, IOP measurement by a Tonopen tonometer (Reichert, Inc., Seefeld, Germany), fundoscopy, an assessment by high-resolution digital retroillumination imaging (detailed protocol presented below).The primary outcomes were the areas of the posterior capsular opening at different postoperative follow-up visits and during operation.A paired T test was used to compare the areas of the PCO between the postoperative visits and baseline.

Detailed Description

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Conditions

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Pediatric Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Participants included eyes of children with unilateral or bilateral cataract.

Exclusion Criteria

Patients with glaucoma, ocular trauma, corneal disorders, persistent hyperplastic primary vitreous, rubella, Lowe syndrome, capsular fibrosis, or surgical complications, as well as those whose pupils could not dilate normally postoperation or who could not complete the follow-up, were excluded.
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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yin ying zhao

yin ying zhao [yyzhao]

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ZHAO YUNE, MD

Role: STUDY_DIRECTOR

executive dean

Locations

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Wenzhou Medical Colledge

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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FU YANA, MD

Role: CONTACT

+8613003605152

Facility Contacts

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Fu yana, MD

Role: primary

+8613003605152

Other Identifiers

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FYN-capsular

Identifier Type: -

Identifier Source: org_study_id

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