Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

NCT ID: NCT02424162

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-11

Study Completion Date

2015-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2.75 group

Patients with 2.75 diopters multifocal intraocular lens

Group Type EXPERIMENTAL

+2.75 diopters multifocal intraocular lens

Intervention Type DEVICE

3.25 group

Patients with +3.25 diopters multifocal intraocular lens

Group Type ACTIVE_COMPARATOR

+3.25 diopters multifocal intraocular lens

Intervention Type DEVICE

Interventions

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+2.75 diopters multifocal intraocular lens

Intervention Type DEVICE

+3.25 diopters multifocal intraocular lens

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0837

Identifier Type: -

Identifier Source: org_study_id

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