Visual and Patient-Reported Outcomes After Bilateral Non-Diffractive EDOF IOL Implantation (EDOF-Visual)

Visual and Patient-Reported Outcomes Following Bilateral Implantation of Non-Diffractive Extended Depth-of-Focus Intraocular Lenses in Patients Undergoing Cataract Surgery

This study evaluates visual outcomes and patient-reported satisfaction following bilateral cataract surgery using a non-diffractive extended depth-of-focus (EDOF) intraocular lens (AcrySof IQ Vivity). The purpose of the study is to assess distance, intermediate, and near visual acuity, refractive accuracy, contrast sensitivity, spectacle independence, and the presence of photic phenomena after implantation. Thirty patients undergoing bilateral phacoemulsification will be enrolled. Participants will be evaluated at 1 and 3 months postoperatively.

Study Overview

• Status: Completed
• Conditions: Cataract; Visual Acuity; Extended Depth-of-Focus Intraocular Lens
• Intervention / Treatment: Device: AcrySof IQ Vivity EDOF Intraocular Lens

Detailed Description

This prospective, single-arm interventional study was designed to evaluate visual performance and patient-reported outcomes following bilateral implantation of a non-diffractive extended depth-of-focus (EDOF) intraocular lens in patients undergoing cataract surgery.

Modern cataract surgery aims not only to restore distance vision but also to provide functional intermediate and near vision while minimizing optical disturbances. Non-diffractive EDOF intraocular lenses utilize wavefront-shaping technology to extend the depth of focus without splitting light, with the objective of maintaining contrast sensitivity and reducing dysphotopsia compared to diffractive multifocal designs.

Eligible patients with age-related cataract underwent standard phacoemulsification cataract surgery with in-the-bag implantation of the study intraocular lens in both eyes. The target postoperative refraction was emmetropia. All procedures were performed under topical anesthesia using a standardized surgical technique. Postoperative treatment consisted of topical antibiotic-steroid therapy with a gradual taper.

Participants were evaluated at predefined postoperative visits to assess visual acuity at multiple distances, refractive status, defocus performance, contrast sensitivity, and patient-reported measures including spectacle independence and visual disturbances.

The study was conducted in accordance with institutional ethical standards and the principles of the Declaration of Helsinki. Ethical approval was obtained from the institutional review board of Al-Azhar University Faculty of Medicine (Approval No. Ophth._12/2023), and written informed consent was obtained from all participants prior to enrollment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13111
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age-related cataract requiring bilateral phacoemulsification
• Corneal astigmatism ≤1.0 diopter
• Desire for postoperative spectacle independence
• Age ≥40 years
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• Previous ocular surgery in either eye
• Glaucoma
• Macular degeneration
• Corneal pathology
• Any ocular comorbidity that may affect visual outcomes
• Systemic conditions likely to affect vision or surgical outcomes
• Inability to comply with postoperative follow-up visits or study assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bilateral Non-Diffractive EDOF IOL Implantation; All participants underwent standard bilateral phacoemulsification cataract surgery with implantation of the AcrySof IQ Vivity non-diffractive extended depth-of-focus (EDOF) intraocular lens in both eyes. Target refraction was emmetropia. Postoperative care included a 4-week taper of combined topical antibiotic-steroid drops. Visual acuity, intermediate and near vision, spectacle independence, patient satisfaction, and photic phenomena were assessed at 1 and 3 months postoperatively.

Device: AcrySof IQ Vivity EDOF Intraocular Lens; The AcrySof IQ Vivity is a non-diffractive extended depth-of-focus intraocular lens designed to provide an extended range of clear vision for distance and intermediate tasks while maintaining high optical quality and reducing photic phenomena such as glare and halos. The lens is implanted in the capsular bag during standard phacoemulsification surgery. Target refraction is emmetropia, and postoperative care includes a 4-week taper of combined topical antibiotic-steroid drops. Outcomes measured include visual acuity at distance, intermediate, and near, patient satisfaction, spectacle independence, and contrast sensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Distance Visual Acuity (UDVA)	Binocular uncorrected distance visual acuity will be measured using standardized logMAR charts under photopic conditions following bilateral implantation of the study intraocular lens.	1 month and 3 months postoperatively
Monocular Uncorrected Distance Visual Acuity (UDVA)	Monocular uncorrected distance visual acuity will be assessed in each eye separately using standardized logMAR charts under photopic conditions.	1 month and 3 months postoperatively
Binocular Uncorrected Intermediate Visual Acuity (UIVA at 66 cm)	Binocular uncorrected intermediate visual acuity at 66 cm will be measured using standardized logMAR charts to evaluate intermediate functional vision.	1 month and 3 months postoperatively
Binocular Uncorrected Near Visual Acuity (UNVA at 40 cm)	Binocular uncorrected near visual acuity at 40 cm will be measured using standardized logMAR charts to assess near functional vision.	1 month and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cataract; Refractive Outcomes; Non-Diffractive IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Ophth_12_2023; Benha University (Other Identifier: Al-Azhar University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD), including de-identified datasets, will not be made publicly available. The study results will be reported in aggregate form in publications and in the ClinicalTrials.gov Results Section.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No