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

Sponsor
tae-young chung (Other)
Overall Status
Unknown status
CT.gov ID
NCT02556944
Collaborator
(none)
40
1
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Phacoemulsification with multifocal intraocular lens
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mix and matched patients

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
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.

Outcome Measures

Primary Outcome Measures

  1. Visual acuity(Distant, intermediate, near) [1month]

Secondary Outcome Measures

  1. Visual acuity(Distant, intermediate, near) [3month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • tae-young chung

Investigators

  • Study Chair: Tae-Young Chung, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
tae-young chung, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02556944
Other Study ID Numbers:
  • 2015-02-001-009
First Posted:
Sep 22, 2015
Last Update Posted:
Sep 22, 2015
Last Verified:
Sep 1, 2015
Keywords provided by tae-young chung, Professor, Samsung Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2015