Binocular Vision Alternations and fMRI Activation After ICL Implantation for High Myopia

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05633212
Collaborator
(none)
50
1
15.5
3.2

Study Details

Study Description

Brief Summary

Implantable collamer lens (ICL) is one of the most effective operation for high myopia. Due to refractive correction changed, and prism effect of the spectacle removed, in the early stage after ICL implantation, binocular function might be dysfunction, leading to asthenopia, blurred vision, double vision and so on. This study will recruit the high myopia subjects that scheduled for ICL implantation, purpose to investigate the binocular vision alternations and brain activation that impacted by ICL implantation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
    Actual Study Start Date :
    Mar 15, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Changes of phoria at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Phoria was measured by phoropter.

    2. Changes of AC/A at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Gradient AC/A was measured by phoropter.

    3. Changes of fusion vergence at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Fusion vergence was measured by phoropter.

    4. Changes of accommodative response at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Accommodative response was measured using monocular estimated method.

    5. Changes of relative accommodation at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Relative accommodation was measured by phoropter.

    6. Changes of near point of convergence at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Near point of convergence was measured using push-up method.

    7. Changes of accommodation amplitude at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Accommodative amplitude was measured using push-up method.

    8. Changes of vergence facility at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Vergence facility was measured by +2.00D/-2.00D flipper.

    9. Changes of accommodative facility at different time points [The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.]

      Accommodative facility was measured by 3△BI/12△BO flipper.

    Secondary Outcome Measures

    1. Changes of brain activation at different time points [The examination was performed before operation and 1 month, 6 monthes after ICL implantation.]

      Functional magnetic resonance imaging activation of the brain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18-35

    • Spherical equivalent over -6.00DS, astigmatism within -2.00DC, anisometropia within -2.00DS

    • BCVA ≥ 0.8

    • Plan to accept implantable collamer lens surgery

    • Near point of convergence within 10cm

    • Positive fusion vergence over 20pd

    Exclusion Criteria:
    • Stabismus

    • Previous ocular surgery or trauma

    • History of vision therapy

    • Monovision and nystagmus

    • Mental disease or craniocerebral trauma

    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

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05633212
    Other Study ID Numbers:
    • 2022KYPJ198
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhongshan Ophthalmic Center, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 1, 2022