Cataract, Extended Depth-of-Focus Intraocular Lens, Visual Acuity
Conditions
Keywords
Refractive Outcomes, cataract, Non-Diffractive IOL
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.
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.
Interventions
DEVICEAcrySof 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.
Sponsors
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Distance Visual Acuity (UDVA) | 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. |
| Monocular Uncorrected Distance Visual Acuity (UDVA) | 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. |
| Binocular Uncorrected Intermediate Visual Acuity (UIVA at 66 cm) | 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. |
| Binocular Uncorrected Near Visual Acuity (UNVA at 40 cm) | 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. |
Countries
Egypt
Outcome results
None listed