Evaluation of Cataract Surgery Outcome

Sponsor
Evidence Based Cataract Study Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT02182921
Collaborator
(none)
20,000
Enrollment
1
Location
136
Duration (Months)
147
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Surgical Outcomes of Cataract Surgery
    Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in visual acuity at one month after cataract surgery [Follow-up until one month after surgery]

    2. Change from baseline in spherical equivalent at one month after cataract surgery [Follow-up until one month after surgery]

    3. Change from baseline in visual acuity at six months after cataract surgery [Follow-up until six months after surgery]

    4. Change from baseline in spherical equivalent at six months after cataract surgery [Follow-up until six months after cataract surgery]

    Secondary Outcome Measures

    1. Change from baseline in wavefront aberration at one month after cataract surgery [Follow-up until one month after surgery]

    2. Change from baseline in contrast sensitivity at one month after cataract surgery [Follow-up until one month after surgery]

    3. Change from baseline in intraocular light scattering at one month after cataract surgery [Follow-up until one month after surgery]

    4. Change from baseline in wavefront aberration at six months after cataract surgery [Follow-up until six months after surgery]

    5. Change from baseline in contrast sensitivity at six months after cataract surgery [Follow-up until six months after surgery]

    6. Change from baseline in intraocular light scattering at six months after cataract surgery [Follow-up until six months after surgery]

    Other Outcome Measures

    1. The difference between attempted and achieved refractive correction at one month after cataract surgery [Follow-up until one month after surgery]

    2. The difference between attempted and achieved refractive correction at six months after cataract surgery [Follow-up until six months after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of cataract

    • Must be able to cooperate with the ophthalmic examination

    Exclusion Criteria:
    • Clinical diagnosis of mental illness

    • Mentally disabled

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Eye and ENT Hospital of Fudan UniversityShanghaiShanghaiChina200031

    Sponsors and Collaborators

    • Evidence Based Cataract Study Group

    Investigators

    • Study Chair: Yi Lu, MD, Eye and ENT Hospital of Fudan University
    • Study Director: Xiangjia Zhu, MD, Eye and ENT Hospital of Fudan University
    • Study Director: Jin Yang, MD, Eye and ENT Hospital of Fudan University
    • Principal Investigator: Keke Zhang, MD, Eye and ENT Hospital of Fudan University
    • Principal Investigator: Wenwen He, MD, Eye and ENT Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    xiangjiazhu, MD, Evidence Based Cataract Study Group
    ClinicalTrials.gov Identifier:
    NCT02182921
    Other Study ID Numbers:
    • NSFC/YOUNG-81100653
    First Posted:
    Jul 8, 2014
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2021