Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power

Not Applicable

• Conditions: Presbyopia
• Interventions: Device: Phacoemulsification with multifocal intraocular lens

• Registration Number: NCT02556944
• Lead Sponsor: tae-young chung

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.

Detailed Description

Multifocal intraocular lens (MIOL) is considered a prevailing alternative to restore the functional vision from far to near independent of glasses. Many clinical studies on diffractive MIOLs, refractive MIOLs, or hybrid MIOLs in enhancing quality of vision showed promising outcomes. Several studies have confirmed the satisfactory visual outcomes of Tecnis MIOL with +4.00 D add power. The purpose of study is to assess the visual performance after cataract surgery with bilateral implantation of multifocal IOL with two different add power (+2.75 D or +3.25 D) in one patient.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-09
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Last Update Submitted: 2015-09-21
• Study First Posted: 2015-09-22
• Last Update Posted: 2015-09-22
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mix and matched patients	Phacoemulsification with multifocal intraocular lens	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.

Primary Outcome Measures

Name	Time	Method
Visual acuity(Distant, intermediate, near)	1month

Secondary Outcome Measures

Name	Time	Method
Visual acuity(Distant, intermediate, near)	3month