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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02556944
• Other study ID #: 2015-02-001-009
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 21, 2015
• Last updated: September 21, 2015
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
tae-young chung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity(Distant, intermediate, near)		1month	Yes
Secondary	Visual acuity(Distant, intermediate, near)		3month	Yes