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Visual Performance of Functional Intraocular Lenses in Cataracts

Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05581888
Enrollment
62
Registered
2022-10-17
Start date
2020-04-01
Completion date
2023-03-31
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, High Myopia

Keywords

Visual performance, Trifocal IOL, High myopic cataract

Brief summary

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.

Detailed description

Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.

Interventions

Binocular implantation of two different trifocal intraocular lens in high myopic cataracts

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* required binocular cataract extraction * age \> 21 years * length of optic axis \> 26 mm

Exclusion criteria

* irregular corneal astigmatism \> 0.3 um; * amblyopia; previous ocular surgery; * ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects; * requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Design outcomes

Primary

MeasureTime frameDescription
best corrected distance visual acuity (BCVA)one yearcorrected visual acuity at 5 m
uncorrected distance visual acuity (UDVA)one yearuncorrected visual acuity at 5 m
uncorrected near visual acuity (UNVA)one yearuncorrected visual acuity at 40 cm
uncorrected intermediate visual acuity (UIVA)one yearuncorrected visual acuity at 60 cm

Secondary

MeasureTime frameDescription
Strehl Ratiothree monthsThe derivative of point spread function (PSF)
objective visual qualitythree monthsMTF curves
HOAsthree monthshigh order aberrations such as coma

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026