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Status unknownNCT05718076Updated Feb 8, 2023

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

An observational study in Myopia and Intraocular Lens Complication, sponsored by Aier School of Ophthalmology, Central South University. Status unknown at 2 sites in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Aier School of Ophthalmology, Central South University · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 80 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Myopia
  • Intraocular Lens Complication

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03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Those who plan to have cataract surgery in the near future

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

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.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • group 1

    Eyes are categorized by fundus META-PM as grade 0

    Procedure: cataract surgery

  • group 2

    Eyes are categorized by fundus META-PM as grade 1

    Procedure: cataract surgery

  • group 3

    Eyes are categorized by fundus META-PM as grade 2

    Procedure: cataract surgery

Interventions

  • Procedurecataract surgery

    Phacoemulsification combined trifocal lens implantation

    Also known as: Phacoemulsification combined trifocal lens implantation

05

What researchers measure

Primary outcomes

  1. Visual acuity

    Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA

    Time frame: 12 months

06

Study locations

2 of 2 sites recruiting
  • Hua Fan
    Shanghai, 200000, China
    • Hua Fan · Contact · fanhua1116@163.com · 18988761617
    • Wensheng Li · Contact · drlws@qq.com · +8618650424985
    • Wensheng Li · Principal investigator
    • Hua Fan · Sub investigator
    Recruiting
  • Shanghai Aier Eye Hospital
    Shanghai, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05718076
Lead sponsor
Aier School of Ophthalmology, Central South University
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Jan 1, 2022
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Wensheng Li
Contact
drlws@qq.com
+8618988761617
Hua Fan
principal investigator · Shanghai Aier Eye Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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