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

NCT ID: NCT05718076

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-01

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Myopia Intraocular Lens Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

Eyes are categorized by fundus META-PM as grade 0

cataract surgery

Intervention Type PROCEDURE

Phacoemulsification combined trifocal lens implantation

group 2

Eyes are categorized by fundus META-PM as grade 1

cataract surgery

Intervention Type PROCEDURE

Phacoemulsification combined trifocal lens implantation

group 3

Eyes are categorized by fundus META-PM as grade 2

cataract surgery

Intervention Type PROCEDURE

Phacoemulsification combined trifocal lens implantation

Interventions

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cataract surgery

Phacoemulsification combined trifocal lens implantation

Intervention Type PROCEDURE

Other Intervention Names

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Phacoemulsification combined trifocal lens implantation

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hua Fan

Role: PRINCIPAL_INVESTIGATOR

Shanghai Aier Eye Hospital

Locations

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Hua Fan

Shanghai, , China

Site Status RECRUITING

Shanghai Aier Eye Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wensheng Li

Role: CONTACT

+8618988761617

Facility Contacts

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Hua Fan

Role: primary

18988761617

Wensheng Li

Role: backup

+8618650424985 ext. +8618650424985

Wensheng Li

Role: primary

+8618988761617

Other Identifiers

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SHAIER2021IRB04-1

Identifier Type: -

Identifier Source: org_study_id

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