Extended Depth-of-Focus Intraocular LensEDOF-VisualNCT07457216
Visual and Patient-Reported Outcomes After Bilateral Non-Diffractive EDOF IOL Implantation
A study testing AcrySof IQ Vivity EDOF Intraocular Lens in people with Extended Depth-of-Focus Intraocular Lens and Cataract, run by Benha University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Extended Depth-of-Focus Intraocular Lens, Cataract, Visual Acuity
- What is being tested?
- AcrySof IQ Vivity EDOF Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2025to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- AcrySof IQ Vivity EDOF Intraocular Lens
- Keywords
- Refractive Outcomes, cataract, Non-Diffractive IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ Vivity EDOF Intraocular LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AcrySof IQ Vivity EDOF Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start3 Jan 2025
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extended Depth-of-Focus Intraocular LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457216
- Sponsor's protocol ID
- Ophth_12_2023
- Other IDs
- Benha University
- Acronym
- EDOF-Visual
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Patient-Reported Outcomes Following Bilateral Implantation of Non-Diffractive Extended Depth-of-Focus Intraocular Lenses in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT07457216
- Acronym / sponsor ID
- EDOF-Visual / Ophth_12_2023
- Keywords
- Refractive Outcomes, cataract, Non-Diffractive IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Non-Diffractive EDOF IOL Implantation | Experimental | Device: AcrySof IQ Vivity EDOF Intraocular LensAll 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Previous ocular surgery in either eye
- Glaucoma
- Macular degeneration
- Corneal pathology
- Any ocular comorbidity that may affect visual outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcrySof IQ Vivity EDOF Intraocular LensThe 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. | Device | Bilateral Non-Diffractive EDOF IOL Implantation |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof IQ Vivity EDOF Intraocular Lens in people with Extended Depth-of-Focus Intraocular Lens and Cataract, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular Uncorrected Distance Visual Acuity (UDVA) (time frame: 1 month and 3 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.