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

tae-young chung

Status: Unknown

Conditions: Presbyopia

Treatments: Device: Phacoemulsification with multifocal intraocular lens

Study type: Interventional

Funder types: Other

Identifiers

NCT02556944

2015-02-001-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Mix and matched patients

Experimental group

Description:

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.

Treatment:

Device: Phacoemulsification with multifocal intraocular lens