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Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02424162
Enrollment
43
Registered
2015-04-22
Start date
2014-11-11
Completion date
2015-11-03
Last updated
2019-02-18

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

Conditions

Cataract

Brief summary

This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction \[MR\]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.

Interventions

DEVICE+2.75 diopters multifocal intraocular lens
DEVICE+3.25 diopters multifocal intraocular lens

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age \>= 18 * cataract patients with lens opacities classification higher than grade III * patients who desire to be spectacle indepence for distance and near vision

Exclusion criteria

* previous ocular surgery or trauma * presence of corneal opacities * fundus abnormalities * glaucoma * uveitis * amblyopia * systemic disease * posterior capsule rupture during cataract surgery

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity3 monthsUncorrected distance visual acuity and uncorrected near visual acuity

Secondary

MeasureTime frameDescription
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system3 monthsInternal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
internal aberration measured by the ray-tracing aberrometer3 monthsInternal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system

Countries

South Korea

Outcome results

None listed

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