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Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

M

Marmara University

Status

Completed

Conditions

Multifocal Intraocular Lenses
Extended Depth of Focus

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04865016
09.2016.309

Details and patient eligibility

About

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.

Full description

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion criteria were patients with bilateral visually significant cataract seeking spectacle independence, especially at far and intermediate distances, age of ≥18 years, preoperative corneal astigmatism less than 1.00 D, axial length (AL) between 21 - 26.5 mm, and availability to attend all follow-up visits.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

MIOL Group
Active Comparator group
Description:
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).
Treatment:
Device: Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)
EDOF Group
Active Comparator group
Description:
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).
Treatment:
Device: Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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