An Interocular Comparative Study of Unilateral Cataract

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT02765230
Collaborator
Ministry of Health, China (Other)
53
Enrollment
1
Location
24
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract.

    Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    53 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    Interocular Anatomical and Visual Functional Differences in Pediatric Patients With Unilateral Cataracts at 3 Months Post-surgery: A Cross-sectional Study
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Jan 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Interocular anatomical parameters in pediatric unilateral cataract patients measured by pentacam [Baseline]

      The Parameters are measured by pentacam (Oculus Inc., Wetzlar, Germany), a rotating Scheimpflug camera.

    2. Visual function in pediatric unilateral cataract patients measured by Teller Acuity Cards [Baseline]

      The visual function is measured by Teller Acuity Cards (Stereo Optical Company, Inc., IL, USA).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children with uncomplicated surgeries

    • Children who were younger than 10 years old

    • Children with unilateral total cataract

    Exclusion Criteria:
    • Premature birth

    • Microphthalmia

    • Micro-or Megalocornea

    • Keratoconus

    • Glaucoma

    • Traumatic or complicated cataracts

    • Vitreous and retinal diseases

    • Any previous surgeries

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Zhongshan Ophthalmic Center, Sun Yat-sen UniversityGuangzhouGuangdongChina510060

    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., 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:
    NCT02765230
    Other Study ID Numbers:
    • CCPMOH2016-China-3
    First Posted:
    May 6, 2016
    Last Update Posted:
    May 6, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2016