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

NCT07457216 | Completed DMC

• 2 other identifiers: Ophth_12_2023Benha University
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extended Depth-of-Focus Intraocular Lens; Cataract; Visual Acuity

Keywords

Refractive Outcomes; cataract; Non-Diffractive IOL

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Bilateral Non-Diffractive EDOF IOL Implantation

EXPERIMENTAL

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

Interventions

AcrySof IQ Vivity EDOF Intraocular Lens DEVICE

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.

Bilateral Non-Diffractive EDOF IOL Implantation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied. Both the surgeon and patients were aware of the intervention. Outcome measures were assessed objectively using standardized visual acuity testing and validated patient questionnaires.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: All participants received bilateral implantation of the AcrySof IQ Vivity non-diffractive EDOF intraocular lens. Visual outcomes and patient-reported measures were assessed at 1 and 3 months postoperatively.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 9, 2026
• Study Start: January 3, 2025
• Primary Completion: January 30, 2025
• Study Completion: January 31, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)