NCT02556944

Brief Summary

To assess postsurgical visual acuity (distant, intermediate, near), refractive errors, contrast sensitivity, visual function and patient satisfaction after implantation of multifocal IOLs of different add power contralaterally.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 21, 2015

Last Update Submit

September 21, 2015

Conditions

Presbyopia

Keywords

Depth of focus

Outcome Measures

Primary Outcomes (1)

  • Visual acuity(Distant, intermediate, near)

    1month

Secondary Outcomes (1)

  • Visual acuity(Distant, intermediate, near)

    3month

Study Arms (1)

Mix and matched patients

EXPERIMENTAL

Mix and matched patients will get phacoemulsification with multifocal intraocular lens implantation with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally.

Device: Phacoemulsification with multifocal intraocular lens

Interventions

Phacoemulsification with multifocal intraocular lensDEVICE

Phacoemulsification and implantation of a multifocal intraocular lens (IOL) with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally. They're called mix and matched patients.

Mix and matched patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age-related cataract
  • Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye.
  • A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation.
  • A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
  • Written informed consent to surgery and participation in the study

You may not qualify if:

  • Pregnant woman and lactating woman
  • A patient with history of retinal disease
  • A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
  • A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
  • A patient that has been wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended -wear or daily soft contact lens within 7 days of their scheduled surgery.
  • Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract, or marfan syndrome
  • Those who are not able to read and understand the informed consent (illiterate or foreigners)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yang CM, Lim DH, Hwang S, Hyun J, Chung TY. Prospective study of bilateral mix-and-match implantation of diffractive multifocal intraocular lenses in Koreans. BMC Ophthalmol. 2018 Mar 7;18(1):73. doi: 10.1186/s12886-018-0735-0.

    PMID: 29514611DERIVED

MeSH Terms

Conditions

Presbyopia

Interventions

PhacoemulsificationMultifocal Intraocular Lenses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical ProceduresLenses, IntraocularLensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Tae-Young Chung, PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

September 22, 2015

Record last verified: 2015-09