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

A Prospective, Observational Study to Investigate Visual Outcome After Trifocal Intraocular Lens Implantation in High Myopic Patient With Different Meta-PM Grading Fundus Appearance.

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 Overview

• Status: Recruiting
• Conditions: Myopia; Intraocular Lens Complication
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Wensheng Li; Phone Number: +8618988761617; Email: drlws@qq.com

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Hua Fan
    • Contact: Hua Fan; Phone Number: 18988761617; Email: fanhua1116@163.com
    • Sub-Investigator: Hua Fan
  • Shanghai, China
    • Recruiting
    • Shanghai Aier Eye Hospital
    • Contact: Wensheng Li; Phone Number: +8618988761617; Email: drlws@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Those who plan to have cataract surgery in the near future

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA	12 months

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Principal Investigator: Hua Fan, Shanghai Aier Eye Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SHAIER2021IRB04-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No