A Novel Congenital Cataract Category System

NCT02793869 | Completed DMC

• 1 other identifier: CCPMOH2016-China-4
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

congenital cataract;anterior segment characteristics

Outcome Measures

Primary Outcomes (3)

• The mean keratometry value

  The anterior segment parametersthe mean keratometry value of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.

  Baseline

• The central corneal thickness

  The anterior segment parametersthe central corneal thickness of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.

  Baseline

• The anterior chamber depth

  The anterior segment parametersthe anterior chamber depth of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.

  Baseline

Study Arms (4)

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.

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.

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.

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This was a prospective study and was included in our series of ongoing studies at the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH), a national project for congenital cataract (CC) treatment and research. CC patients less than 18 years old and seeking treatment at the ZOC, one of the best eye care facilities in China, from February 2011 to December 2015 were candidates for this study. All included participants were diagnosed with CC before surgery and lacked other ocular abnormalities, such as severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus. A total of 428 CC patients were included.

You may qualify if:

• Diagnosis of congenital cataract
• less than 18 years old

You may not qualify if:

• With other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 26339020 BACKGROUND

Related Links

• Description Home page of Zhongshan Ophthalmic Center
• Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Haotian Lin, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yizhi Liu, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

• Weirong Chen, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 8, 2016
• Study Start: February 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

CN (1)