Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract

NCT ID: NCT04441268

Last Updated: 2020-06-22

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

COMPLETED

Total Enrollment

335 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2019-12-30

Brief Summary

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The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Detailed Description

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Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital cataract. The developmental profile of refraction among patient with congenital catarat is has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC children.After primary IOL implatation, routine examinations including retinoscopy were completed. Data were analysed to to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract and to explore key factors associated with the rate of change.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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primary IOL implantation

implant IOL in capsular bag after cataract extraction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with uncomplicated surgeries
* Children with unilateral/bilateral cataract

Exclusion Criteria

* Corneal diseases
* Lens luxation
* Glaucoma
* Retinal diseases
* Nystagmus and nanophthalmos
Minimum Eligible Age

7 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen Weirong, MD

Role: STUDY_CHAIR

SunYat-sen University

Locations

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Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CCPMOH2020-China-2

Identifier Type: -

Identifier Source: org_study_id

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