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

Myopia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718076
• Other study ID #: SHAIER2021IRB04-1
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Aier School of Ophthalmology, Central South University
• Contact: Wensheng Li
• Phone: +8618988761617
• Email: drlws[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Lens Complication
• Myopia

Intervention

Procedure:
• cataract surgery
Phacoemulsification combined trifocal lens implantation

Locations

Country	Name	City	State
China	Hua Fan	Shanghai
China	Shanghai Aier Eye Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA	12 months