Clinical trial NCT02556944: Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
Official title: Mix and Match Study of Two Multifocal Intraocular Lens With Different Add Power
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyopia
Keywords: Depth of focus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Visual acuity(Distant, intermediate, near)
timeFrame: 1month
Secondary outcomes:
measure: Visual acuity(Distant, intermediate, near)
timeFrame: 3month
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Tae-Young Chung, PhD
role: STUDY_CHAIR
References:
citation: 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.