Comparison of a Novel Non-diffractive Extended Depth of Focus Intraocular Lens (IOL) and a Trifocal IOL

NCT05262504 | Completed FDA Device

• 1 other identifier: Vivity Panoptix
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances

  uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance corrected intermediate visual acuity (DCIVA), distance corrected near visual acuity (DCNVA)

  postoperative third month

• Defocus-curves

  The monocular defocus curves were evaluated under photopic conditions using defocusing lenses from +0.50 D to -4.00 D in 0.50 D steps. The measurements were performed by adding the lenses to the CDVA.

  postoperative third month

• Contrast sensitivity

  Monocular and binocular contrast sensitivity was assessed with the Pelli-Robson chart under photopic conditions at 3 meters.

  postoperative third month

• Reading speed

  Reading speed was measured using the validated Turkish version of the MNREAD chart in photopic illumination conditions. It was recorded as number of words read by the patient in one minute (words per minute-wpm).

  postoperative third month

• Quality of vision / dysphotopsia

  Dysphotopsia was assessed by the Quality of Vision (QoV) questionnaire developed by McAlinden et al. The QoV is a validated Rasch-adjusted questionnaire in which patients are asked to rate specific dysphotopsia items depicted in standard photographs. Patients score each item (0, 1, 2, or 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total). Lower QoV scores indicate a better quality of vision.

  postoperative third month

• Vision-related quality of life (QOL)

  The vision-related QOL was assessed three months after the surgery by the VF-14 QOL questionnaire that was administered face-to-face by a trained researcher (İK). The grading scale was as follows: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Special care was taken not to influence the patients and to ensure that each question was fully understood.

  postoperative third month

Study Arms (2)

EDOF IOL Group

Patients who were implanted with the novel wavefront shaping extended depth of focus IOL

Device: İntraocular lens implantation

Multifocal IOL group

Patients who were implanted with the multifocal IOL

Device: İntraocular lens implantation

Interventions

İntraocular lens implantation DEVICE

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 interval between the first and second-eye surgeries was 1 to 3 weeks. 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.

EDOF IOL Group; Multifocal IOL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Baskent University Faculty of Medicine

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (1)

• Asena L, Kirci Dogan I, Oto S, Dursun Altinors D. Comparison of visual performance and quality of life with a new nondiffractive EDOF intraocular lens and a trifocal intraocular lens. J Cataract Refract Surg. 2023 May 1;49(5):504-511. doi: 10.1097/j.jcrs.0000000000001142.

  PMID: 36700928 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sibel Oto, MD

  Baskent University Faculty of Medicine Department of Ophthalmology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TU (1)