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

Study Overview
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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).

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

Conditions
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Myopia, Intraocular Lens Complication

Intervention / Treatment
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* Procedure: cataract surgery


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>Eyes are categorized by fundus META-PM as grade 0 | Procedure: cataract surgery<br>* Phacoemulsification combined trifocal lens implantation<br>* Other names: Phacoemulsification combined trifocal lens implantation;|
| group 2<br>Eyes are categorized by fundus META-PM as grade 1 | Procedure: cataract surgery<br>* Phacoemulsification combined trifocal lens implantation<br>* Other names: Phacoemulsification combined trifocal lens implantation;|
| group 3<br>Eyes are categorized by fundus META-PM as grade 2 | Procedure: cataract surgery<br>* Phacoemulsification combined trifocal lens implantation<br>* Other names: Phacoemulsification combined trifocal lens implantation;|

What is the study measuring?
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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 |