Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

NCT ID: NCT02761850

Last Updated: 2016-05-05

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

1164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.

Detailed Description

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The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized.

The investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yizhi Liu, M.D., Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Weirong Chen, M.D., Ph.D

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.

Reference Type BACKGROUND
PMID: 26339020 (View on PubMed)

Related Links

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http://www.gzzoc.com/

Home page of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2016-China-2

Identifier Type: -

Identifier Source: org_study_id

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