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

NCT ID: NCT02556944

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Phacoemulsification with multifocal intraocular lens

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

tae-young chung

OTHER

Sponsor Role: lead

Responsible Party

tae-young chung

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tae-Young Chung, PhD

Role: STUDY_CHAIR

Samsung Medical Center

References

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.

Reference Type: DERIVED

PMID: 29514611 (View on PubMed)

Other Identifiers

2015-02-001-009

Identifier Type: -

Identifier Source: org_study_id