Trifocal Intraocular Lens in High Myopic Patients With Different Meta-PM Grading
A Prospective, Observational Study to Investigate Visual Outcome After Trifocal Intraocular Lens Implantation in High Myopic Patient With Different Meta-PM Grading Fundus Appearance.
1 other identifier
observational
60
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 8, 2023
January 1, 2023
1.9 years
January 30, 2023
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
Monocular BCVA, UCVA(5m), BCIVA, UIVA(60cm) and BCNVA, UNVA(40cm) VA
12 months
Study Arms (3)
group 1
Eyes are categorized by fundus META-PM as grade 0
group 2
Eyes are categorized by fundus META-PM as grade 1
group 3
Eyes are categorized by fundus META-PM as grade 2
Interventions
Phacoemulsification combined trifocal lens implantation
Eligibility Criteria
Those who plan to have cataract surgery in the near future
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hua Fan
Shanghai, 200000, China
Shanghai Aier Eye Hospital
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hua Fan
Shanghai Aier Eye Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2023
First Posted
February 8, 2023
Study Start
January 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 8, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share