A Novel Congenital Cataract Category System

NCT ID: NCT02793869

Last Updated: 2016-06-08

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

428 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.

Detailed Description

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Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.

Using the largest CC database in the Zhongshan Ophthalmic Center (ZOC), the current study compared the anterior segment characteristics of CC patients with lens opacities in different positions and further proposed a modified CC category system based on the specific relationships between the position of lens opacities and anterior segment characteristics. Knowledge of these relationships is beneficial for further understanding of CC occurrence and development and has clinical significance for CC diagnosis and treatment.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Total cataract group

All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis.

No interventions assigned to this group

Anterior cataract group

All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis.

No interventions assigned to this group

Interior cataracts group

All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis.

No interventions assigned to this group

Posterior cataract group

All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of congenital cataract
* less than 18 years old

Exclusion Criteria

* With other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.
Maximum Eligible Age

18 Years

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/

Description Home page of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2016-China-4

Identifier Type: -

Identifier Source: org_study_id

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