Visual Outcomes of Functional Intraocular Lenses in Cataracts

Eye & ENT Hospital of Fudan University (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses(bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

    Study Design

    Study Type:
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2029
    Anticipated Study Completion Date :
    Dec 30, 2031

    Outcome Measures

    Primary Outcome Measures

    1. uncorrected distance visual acuity (UDVA) [one year]

      uncorrected visual acuity at 5 m

    2. best corrected distance visual acuity (BCVA) [one year]

      corrected visual acuity at 5 m

    3. uncorrected near visual acuity (UNVA) [one year]

      uncorrected visual acuity at 40 cm

    4. uncorrected intermediate visual acuity (UIVA) [one year]

      uncorrected visual acuity at 60 cm

    Secondary Outcome Measures

    1. HOAs [three months]

      high order aberrations such as coma

    2. Strehl Ratio [three months]

      The derivative of point spread function (PSF)

    3. objective visual quality [three months]

      The modulation transfer function (MTF) curve

    4. contrast sensitivity [three months]

      Contrast sensitivity were obtained from the Functional Vision Analyzer

    5. visual functions [three months]

      Visual functions were obtained from the OCULUS Binoptometer 4P

    6. IOL condition [three months]

      IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    7. subjective satisfaction [three years]

      Satisfaction Questionnaire

    8. photic phenomena [three years]

      Questionnaire of photic phenomena

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • cataract

    • age > 18 years

    Exclusion Criteria:
    • amblyopia; previous ocular surgery;

    • ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;

    • requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Eye & ENT Hospital of Fudan University


    • Study Director: Jin Yang, Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Jin Yang, Professor, Eye & ENT Hospital of Fudan University Identifier:
    Other Study ID Numbers:
    • IOL Outcomes in cataracts
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 23, 2023