Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-03-01

Brief Summary

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The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision.

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Detailed Description

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The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision. In this regard, binocular logMAR uncorrected visual acuities (UVA), monocular defocus curves, CS with CSV 1000-E and Pelli-Robson Test (PRT), spectacle needs and quality of life parameters with NEI RQL-42 questionnaire were evaluated at postoperative 1, 3, and 6 months.

Conditions

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Multifocal Intraocular Lenses Extended Depth of Focus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIOL Group

30 eyes of 15 cataract patients undergoing cataract surgery were implanted with a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group).

Group Type ACTIVE_COMPARATOR

Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

Intervention Type DEVICE

This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

EDOF Group

30 eyes of 15 cataract patients undergoing cataract surgery were implanted with an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

Group Type ACTIVE_COMPARATOR

Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

Intervention Type DEVICE

This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

Interventions

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Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

Patients were excluded from the study if any of the following conditions were present: high visual demand for near vision, amblyopia, glaucoma, corneal opacity, severe/moderate to severe dry eye, pupillary abnormalities and dysfunction, corneal astigmatism ≥1.00 D, AL \<21 mm or ≥26.5 mm, diabetes mellitus with retinal changes, active uveitis or history of uveitis, previous ocular surgery and lack of attendance to any follow-up visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No