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NCT Number: NCT07457216

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

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.

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Key information

Conditions

Extended Depth-of-Focus Intraocular Lens Cataract Eye Diseases Lens Diseases Visual Acuity

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Benha, 13111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 1 month and 3 months postoperatively

    Binocular uncorrected distance visual acuity will be measured using standardized logMAR charts under photopic conditions following bilateral implantation of the study intraocular lens.

  2. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 1 month and 3 months postoperatively

    Monocular uncorrected distance visual acuity will be assessed in each eye separately using standardized logMAR charts under photopic conditions.

  3. Binocular Uncorrected Intermediate Visual Acuity (UIVA at 66 cm)

    Time frame: 1 month and 3 months postoperatively

    Binocular uncorrected intermediate visual acuity at 66 cm will be measured using standardized logMAR charts to evaluate intermediate functional vision.

  4. Binocular Uncorrected Near Visual Acuity (UNVA at 40 cm)

    Time frame: 1 month and 3 months postoperatively

    Binocular uncorrected near visual acuity at 40 cm will be measured using standardized logMAR charts to assess near functional vision.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: EDOF-Visual

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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