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Trifocal Intraocular Lens in High Myopic Patients With Different Meta-PM Grading

Sponsor
Aier School of Ophthalmology, Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05718076
Collaborator
(none)
60
Enrollment
2
Locations
23
Anticipated Duration (Months)
30
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to Meta-PM staging (stage 0-2).

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery

Detailed Description

Cataracts occur in patients with high myopia who are younger than age related cataract patients. These relatively young cataract patients have a higher demand for lens removal, and therefore have a higher acceptance of multifocal intraocular lenses. Some current studies have shown that the implantation of multifocal intraocular lenses in patients with high myopia has achieved good visual effects after surgery. As we all know, high myopia is associated with a higher incidence of postoperative complications, and high myopia macular degeneration can affect postoperative visual effects and patient satisfaction. However, there is no research to evaluate the clinical effect of multifocal intraocular lens implantation in patients with high myopia according to different fundus Meta-PM classifications.Therefore, the purpose of this study is to study the postoperative visual quality and safety of trifocal intraocular lenses implanted in patients with different levels of myopic maculopathy stages according to Meta-PM staging (stage 0-2).

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Observational Study to Investigate Visual Outcome After Trifocal Intraocular Lens Implantation in High Myopic Patient With Different Meta-PM Grading Fundus Appearance.
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
group 1

Eyes are categorized by fundus META-PM as grade 0

Procedure: cataract surgery
Phacoemulsification combined trifocal lens implantation
Other Names:
  • Phacoemulsification combined trifocal lens implantation

    		•
    group 2

    Eyes are categorized by fundus META-PM as grade 1

    Procedure: cataract surgery
    Phacoemulsification combined trifocal lens implantation
    Other Names:
  • Phacoemulsification combined trifocal lens implantation

    		•
    group 3

    Eyes are categorized by fundus META-PM as grade 2

    Procedure: cataract surgery
    Phacoemulsification combined trifocal lens implantation
    Other Names:
  • Phacoemulsification combined trifocal lens implantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [12 months]

      Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Age-related cataract 26mm ≤ AL ≤ 30mm Pre-op corneal astigmatism ≤ 1.0 D (IOLMaster 700, Carl Zeiss Meditec AG); Eyes with angle kappa ≤ 0.50 mm (iTrace); Eyes with corneal spherical aberration ≤ 0.30 (iTrace); High order aberration ≤ 0.3 (iTrace). 2.2 ≤ pupil size ≤ 5.5mm Meta-PM classification grade 0, 1 and grade 2 with low risk of MM progression No maculopathy(complete and continuous macular retinal structure revealed by OCT)

    Exclusion Criteria:

    Combined with Glaucoma, serious fundus pathological change, intracranial tumor Any systemic disease may cause secondary vision impair Synechia Other ocular surgery history history of serious cardiopulmonary or cerebrovascular diseases, and serious mental and psychological diseases Sensitive, anxiety perfectionist Any myopic macular lesion, Posterior staphyloma, any Plus lesions in meta-PM classification, including but not limited to CNV, lacquer cracks, dome-shaped macula, Fuchs spot, etc.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hua Fan Shanghai China 200000
    2 Shanghai Aier Eye Hospital Shanghai China

    Sponsors and Collaborators

    • Aier School of Ophthalmology, Central South University

    Investigators

    • Principal Investigator: Hua Fan, Shanghai Aier Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aier School of Ophthalmology, Central South University
    ClinicalTrials.gov Identifier:
    NCT05718076
    Other Study ID Numbers:
    • SHAIER2021IRB04-1
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Jan 1, 2023
    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
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Feb 8, 2023