NCT07457216

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-01-30
• Completion: 2025-01-31
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Egypt