Clinical trial NCT04865016: Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens
Official title: Clinical Outcomes With a Low Add Multifocal and an Extended Depth of Focus Intraocular Lenses Both Implanted With Mini-monovision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multifocal Intraocular Lenses
Extended Depth of Focus
Keywords: low add multifocal intraocular lens, MIOL, ZKB00, extended depth of focus, EDOF, ZXR00, mini-monovision
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The visual acuity
timeFrame: Preoperative
measure: The visual acuity
timeFrame: Postoperative 1st month
measure: The visual acuity
timeFrame: Postoperative 3rd month
measure: The visual acuity
timeFrame: Postoperative 6th month
measure: The contrast sensitivity (CS),
timeFrame: Preoperative
measure: The contrast sensitivity (CS),
timeFrame: Postoperative 1st month
measure: The contrast sensitivity (CS),
timeFrame: Postoperative 3rd month
measure: The contrast sensitivity (CS),
timeFrame: Postoperative 6th month
measure: Quality of life measurement
timeFrame: Preoperative
measure: Quality of life measurement
timeFrame: Postoperative 1st month
measure: Quality of life measurement
timeFrame: Postoperative 3rd month
measure: Quality of life measurement
timeFrame: Postoperative 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Department of Ophthalmology
Study officials:
affiliation: Marmara University
name: Ayse Ebru Toker, Professor
role: STUDY_DIRECTOR
References:
citation: Rosen E, Alio JL, Dick HB, Dell S, Slade S. Efficacy and safety of multifocal intraocular lenses following cataract and refractive lens exchange: Metaanalysis of peer-reviewed publications. J Cataract Refract Surg. 2016 Feb;42(2):310-28. doi: 10.1016/j.jcrs.2016.01.014.
citation: Kim JS, Jung JW, Lee JM, Seo KY, Kim EK, Kim TI. Clinical Outcomes Following Implantation of Diffractive Multifocal Intraocular Lenses With Varying Add Powers. Am J Ophthalmol. 2015 Oct;160(4):702-9.e1. doi: 10.1016/j.ajo.2015.07.021. Epub 2015 Jul 21.
citation: Kretz FT, Gerl M, Gerl R, Muller M, Auffarth GU; ZKB00 Study Group. Clinical evaluation of a new pupil independent diffractive multifocal intraocular lens with a +2.75 D near addition: a European multicentre study. Br J Ophthalmol. 2015 Dec;99(12):1655-9. doi: 10.1136/bjophthalmol-2015-306811. Epub 2015 May 18.
citation: Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.