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Developmental Profile of Ocular Refraction in Patients With Congenital Cataract

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT02761850
Collaborator
Ministry of Health, China (Other)
1,164
Enrollment
1
Location
72
Duration (Months)
16.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1164 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. The refraction status (presented as spherical equivalent, SE) [Baseline]

      Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children with uncomplicated surgeries

    • Children with unilateral/bilateral cataract

    Exclusion Criteria:

    • Corneal diseases

    • Lens luxation

    • Glaucoma

    • Retinal diseases

    • Nystagmus and nanophthalmos

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University
    • Ministry of Health, China

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02761850
    Other Study ID Numbers:
    • CCPMOH2016-China-2
    First Posted:
    May 4, 2016
    Last Update Posted:
    May 5, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of May 5, 2016