Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

Yonsei University1 site in 1 country43 target enrollmentNovember 11, 2014

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Yonsei University
Enrollment: 43
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 11, 2014

End Date

November 3, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

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
•amblyopia
•systemic disease
•posterior capsule rupture during cataract surgery

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: 3 months

Uncorrected distance visual acuity and uncorrected near visual acuity

Secondary Outcomes

Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system(3 months)
internal aberration measured by the ray-tracing aberrometer(3 months)