Clinical trial NCT05262504: Comparison of a Novel Non-diffractive Extended Depth of Focus Intraocular Lens (IOL) and a Trifocal IOL
Official title: Comparison of Visual Performance and Quality of Life With a Novel Non-diffractive Extended Depth-of-focus IOL and a Trifocal IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Lens
Cataract
Quality of Life
Keywords: cataract
wavefront shaping
extended depth of focus
trifocal
intraocular lens
quality of life
defocus curve
contrast sensitivity
photic disturbance
Lead sponsor: Baskent University Ankara Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 104 eyes of 52 consecutive patients with bilateral cataracts operated between April and September 2021 were included. All patients were interested in spectacle independence. Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.

Brief summary: The purpose of this study is to compare visual performance and quality of life (QOL) following bilateral implantation of a novel non-diffractive extended depth-of-focus (EDOF) intraocular lens (IOL) (AcrySof® IQ Vivity, Alcon, TX, USA) and a trifocal IOL (Acrysof® IQ PanOptix, Alcon, Fort Worth, TX) in a prospective comparative interventional case series.

Detailed description: Developments in cataract surgical devices and intraocular lenses (IOL) increased patient expectations and changed the practice patterns in ophthalmology. Nowadays, cataract surgery is considered as a refractive surgery. With multifocal IOLs, spectacle independence can be achieved with a good distance, intermediate and near visual acuity. This is associated with increased quality of life after cataract surgery.The most important disadvantages of multifocal IOLs are loss of contrast sensitivity and photic phenomena such as glare and halo. Although multifocal IOLs are more frequently associated with photic disturbances than monofocal IOLs, the trifocal IOLs have improved performance in photic phenomena when compared to bifocal IOLs. Recently, a new technology known as extended depth of focus (EDOF) IOLs have been developed. These lenses create a single elongated focal point to enhance the depth of focus, improving intermediate vision without compromising distance vision. Although EDOF IOLs provide better intermediate distance vision when compared to monofocal IOLs, near vision is not as good as trifocal IOLs. The most important advantage provided by the EDOF technology is lower rate of photic disturbances than trifocal IOL designs. The aim of this study was to compare the visual performance and patient-reported quality of life (QOL) outcomes following bilateral implantation of a novel non-diffractive wavefront shaping EDOF IOL (AcrySof® IQ Vivity, Alcon Research, TX, USA) and a trifocal IOL (AcrySof® IQ PanOptix, Alcon Laboratories, Fort Worth, TX).

Eligibility criteria: Inclusion Criteria:

* Cataract patients scheduled for surgery who are interested in spectacle independence.
* Bilateral cataract with plan of bilateral sequential cataract surgery.
* Adult patients older than 18 years of age
* Normal cognitive function, able to understand advantages and disadvantages associated with different types of IOLs.

Exclusion Criteria:

* Ocular diseases other than cataract including irregular astigmatism, diabetic retinopathy, age-related macular degeneration or any other retinal diseases, severe dry eye, glaucoma, amblyopia, uveitis, pseudoexfoliation syndrome, abnormal pupillary function, history of intraocular or corneal surgery, congenital eye abnormalities, or eye trauma.
* Patients with high myopia with axial length (AL) ≥ 26,5 mm and high hyperopia (AL ≤ 21.5 mm)
* Lifestyle and work-related factors requiring sharp near or distance vision
* Patients with unrealistic visual expectations.

Primary outcomes:
measure: Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances
timeFrame: postoperative third month
measure: Defocus-curves
timeFrame: postoperative third month
measure: Contrast sensitivity
timeFrame: postoperative third month
measure: Reading speed
timeFrame: postoperative third month
measure: Quality of vision / dysphotopsia
timeFrame: postoperative third month
measure: Vision-related quality of life (QOL)
timeFrame: postoperative third month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Medicine
Study officials:
affiliation: Baskent University Faculty of Medicine Department of Ophthalmology
name: Sibel Oto, MD
role: STUDY_CHAIR
References: