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

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ClinicalTrials.gov Identifier: NCT02556944
Recruitment Status : Unknown
Verified September 2015 by tae-young chung, Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
tae-young chung, Samsung Medical Center

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
Presbyopia Device: Phacoemulsification with multifocal intraocular lens Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

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.




Primary Outcome Measures :
  1. Visual acuity(Distant, intermediate, near) [ Time Frame: 1month ]

Secondary Outcome Measures :
  1. Visual acuity(Distant, intermediate, near) [ Time Frame: 3month ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556944


Sponsors and Collaborators
tae-young chung
Investigators
Study Chair: Tae-Young Chung, PhD Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: tae-young chung, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02556944     History of Changes
Other Study ID Numbers: 2015-02-001-009
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by tae-young chung, Samsung Medical Center:
Depth of focus

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases