Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: +2.75 diopters multifocal intraocular lens; Device: +3.25 diopters multifocal intraocular lens

• Registration Number: NCT02424162
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-11
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2015-11-03
• Study Completion: 2015-11-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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Exclusion Criteria

• previous ocular surgery or trauma
• presence of corneal opacities
• fundus abnormalities
• glaucoma
• uveitis
• amblyopia
• systemic disease
• posterior capsule rupture during cataract surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.75 group	+2.75 diopters multifocal intraocular lens	Patients with 2.75 diopters multifocal intraocular lens
3.25 group	+3.25 diopters multifocal intraocular lens	Patients with +3.25 diopters multifocal intraocular lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Uncorrected distance visual acuity and uncorrected near visual acuity

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system	3 months	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
internal aberration measured by the ray-tracing aberrometer	3 months	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

Trial Locations

Locations (1)

Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of