NCT02424162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2015

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

April 17, 2015

Last Update Submit

February 14, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Uncorrected distance visual acuity and uncorrected near visual acuity

    3 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

2.75 group

EXPERIMENTAL

Patients with 2.75 diopters multifocal intraocular lens

Device: +2.75 diopters multifocal intraocular lens

3.25 group

ACTIVE COMPARATOR

Patients with +3.25 diopters multifocal intraocular lens

Device: +3.25 diopters multifocal intraocular lens

Interventions

+2.75 diopters multifocal intraocular lensDEVICE
2.75 group
+3.25 diopters multifocal intraocular lensDEVICE
3.25 group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 102-752, South Korea

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

November 11, 2014

Primary Completion

November 3, 2015

Study Completion

November 3, 2015

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

KR(1)