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

Recruiting

• Conditions: Myopia; Intraocular Lens Complication
• Interventions: Procedure: cataract surgery

• Registration Number: NCT05718076
• Lead Sponsor: Aier School of Ophthalmology, Central South University

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).

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 Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 3	cataract surgery	Eyes are categorized by fundus META-PM as grade 2
group 1	cataract surgery	Eyes are categorized by fundus META-PM as grade 0
group 2	cataract surgery	Eyes are categorized by fundus META-PM as grade 1

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 months	Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA

Trial Locations

Locations (2)

Hua Fan; 🇨🇳 Shanghai, China

Shanghai Aier Eye Hospital; 🇨🇳 Shanghai, China