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A Novel Congenital Cataract Category System

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ClinicalTrials.gov Identifier: NCT02793869
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

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.

Condition or disease
Cataract

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 428 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Congenital Cataract Category System Based on Lens Opacity Positions and Their Relevant Anterior Segment Characteristics
Study Start Date : February 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort
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.



Primary Outcome Measures :
  1. The mean keratometry value [ Time Frame: Baseline ]
    The anterior segment parametersthe mean keratometry value of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.

  2. The central corneal thickness [ Time Frame: Baseline ]
    The anterior segment parametersthe central corneal thickness of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.

  3. The anterior chamber depth [ Time Frame: Baseline ]
    The anterior segment parametersthe anterior chamber depth of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793869


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
Investigators
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Principal Investigator: Haotian Lin, M.D., Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Chair: Yizhi Liu, M.D., Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Director: Weirong Chen, M.D., Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Additional Information:
Publications:
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Responsible Party: Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02793869     History of Changes
Other Study ID Numbers: CCPMOH2016-China-4
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Haotian Lin, Sun Yat-sen University:
congenital cataract;anterior segment characteristics

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases