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Completed

NCT Number: NCT02424162

Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 102-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

+2.75 diopters multifocal intraocular lens

Device

+3.25 diopters multifocal intraocular lens

Device

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Uncorrected distance visual acuity and uncorrected near visual acuity

Secondary outcomes

  1. Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system

    Time frame: 3 months

    Internal 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

  2. internal aberration measured by the ray-tracing aberrometer

    Time frame: 3 months

    Internal 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2015
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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