Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424162
• Other study ID #: 4-2014-0837
• Status: Completed
• Phase: N/A
• Start date: November 11, 2014
• Est. completion date: November 3, 2015

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 3, 2015
• Est. primary completion date: November 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age >= 18

• cataract patients with lens opacities classification higher than grade III

• patients who desire to be spectacle indepence for distance and near vision

Exclusion Criteria:

• previous ocular surgery or trauma

• presence of corneal opacities

• fundus abnormalities

• glaucoma

• uveitis

• amblyopia

• systemic disease

• posterior capsule rupture during cataract surgery

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• +2.75 diopters multifocal intraocular lens

• +3.25 diopters multifocal intraocular lens

Locations

Country	Name	City	State
Korea, Republic of	Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Uncorrected distance visual acuity and uncorrected near visual acuity	3 months
Secondary	Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system	Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system	3 months
Secondary	internal aberration measured by the ray-tracing aberrometer	Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system	3 months