Age-related CataractNCT07548294
EDOF vs Enhanced vs Monofocal IOLs After Bilateral Cataract Surgery
An observational study of Age-related Cataract, run by Sakarya Yenikent State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Consecutive comparative case series evaluating visual outcomes and patientreported satisfaction after bilateral cataract surgery with implantation of the same IOL type (standard monofocal, enhanced monofocal, or novel EDOF IOL). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Age-related Cataract
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 20 Jan 2025
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All sex, Ages: 45-75 years, Healthy Volunteers: No
Who may be able to join
- Age-related cataract in both eyes
- Eligible for bilateral IOL implantation
- Willingness to return for scheduled follow-up
Who cannot join
- Preoperative corneal astigmatism > 1.0 D
- Axial length >21 mm or <26 mm
- Previous intraocular or corneal surgery
- Ocular comorbidities affecting vision (severe dry eye, amblyopia, ocular surface disease, corneal pathology, retinal diseases, uveitis, glaucoma, pseudoexfoliation, pterygium)
- Intraoperative or postoperative complications, or failure to complete 6-month follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Yenikent State Hospital
Sakarya, Adapazarı, 54140
About this study
Official title: Expanding Visual Horizons: Comparative Outcomes of a Novel Extended Depth-of-Focus IOL Versus Enhanced and Standard Monofocal IOLs
Consecutive comparative case series evaluating visual outcomes and patientreported satisfaction after bilateral cataract surgery with implantation of the same IOL type (standard monofocal, enhanced monofocal, or novel EDOF IOL). Outcomes assessed at 6 months included uncorrected visual acuity at distance, intermediate, and near; refraction; defocus curves; and questionnaires on halos, glare, and spectacle independence.
Read the detailed description
Patients undergoing bilateral phacoemulsification for age-related cataract received one of three IOLs in both eyes: Tecnis ZCB00 (monofocal), Tecnis Eyhance ICB00 (enhanced monofocal), or Asqelio EDOF ETLIO130C (EDOF). Follow-up examinations were performed at 1 day, 1 week, 1 month, 3 months, and 6 months. The 6-month assessment included monocular and binocular visual acuity at distance (6 m), intermediate (66 cm), and near (40 cm), manifest and objective refraction, binocular defocus curves (+1.00 D to -2.50 D in 0.50 D steps), and patient questionnaires (NEI-RQL-42 glare items; custom spectacle independence and satisfaction survey).
- Conditions
- Age-related Cataract
- Keywords
- CATARACT SURGERY, DEFOCUS CURVE, Extended depth-of-focus, Enhanced monofocal, Visual acuity, Patient satisfaction, Intraocular lens
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monofocal IOL | Tecnis ZCB00 (Johnson \& Johnson Vision) | |
| Enhanced monofocal IOL | Tecnis Eyhance ICB00 (Johnson \& Johnson Vision) | |
| EDOF IOL | Asqelio EDOF ETLIO130C (AST Products) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Outcomes
- Binocular uncorrected distance visual acuity (UDVA) at 6 m, logMAR
- Binocular uncorrected intermediate visual acuity (UIVA) at 66 cm, logMAR
- Binocular uncorrected near visual acuity (UNVA) at 40 cm, logMAR
Measured: 6 months
Patient satisfaction score
The patients were asked about their satisfaction with the refractive outcome, as used in International Multicenter Concerto Study as follows: How satisfied are you with your spectacle-free vision at far/intermediate/near distance? The answer choices ranged from 0 (not at all satisfied) to 10 (very satisfied).
Measured: postoperative 6 months
Secondary outcomes (4)
Visual acuity
- Monocular UDVA, UIVA, UNVA (logMAR)
- Monocular and binocular corrected visual acuity (CDVA, CIVA, CNVA) (logMAR)
Measured: 6 months
Objective refraction
Manifest and objective refraction (spherical equivalent) (Diyoptri)
Measured: 6 months
Defocus curve
Binocular defocus curve performance (+1.00 D to -2.50 D) (diyoptri)
Measured: 6 months
Photic phenomena
Halo and glare scores (NEI-RQL-42 items 17 and 38; (0-100 scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start5 Jan 2022
- Primary completion25 Feb 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya Yenikent State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Altan Ertan Boz, Sakarya Yenikent State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548294
- Sponsor's protocol ID
- 2022/294
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Visual Horizons: Comparative Outcomes of a Novel Extended Depth-of-Focus IOL Versus Enhanced and Standard Monofocal IOLs
- ClinicalTrials.gov ID
- NCT07548294
- Acronym / sponsor ID
- 2022/294
- Conditions
- Age-related Cataract
- Keywords
- CATARACT SURGERY, DEFOCUS CURVE, Extended depth-of-focus, Enhanced monofocal, Visual acuity, Patient satisfaction, Intraocular lens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Sakarya Yenikent State HospitalUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 23 Apr 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.
Consecutive comparative case series evaluating visual outcomes and patientreported satisfaction after bilateral cataract surgery with implantation of the same IOL type (standard monofocal, enhanced monofocal, or novel EDOF IOL). Outcomes assessed at 6 months included uncorrected visual acuity at distance, intermediate, and near; refraction; defocus curves; and questionnaires on halos, glare, and spectacle independence.
Detailed description
Patients undergoing bilateral phacoemulsification for age-related cataract received one of three IOLs in both eyes: Tecnis ZCB00 (monofocal), Tecnis Eyhance ICB00 (enhanced monofocal), or Asqelio EDOF ETLIO130C (EDOF). Follow-up examinations were performed at 1 day, 1 week, 1 month, 3 months, and 6 months. The 6-month assessment included monocular and binocular visual acuity at distance (6 m), intermediate (66 cm), and near (40 cm), manifest and objective refraction, binocular defocus curves (+1.00 D to -2.50 D in 0.50 D steps), and patient questionnaires (NEI-RQL-42 glare items; custom spectacle independence and satisfaction survey).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monofocal IOL | – | –Tecnis ZCB00 (Johnson \& Johnson Vision) |
| Enhanced monofocal IOL | – | –Tecnis Eyhance ICB00 (Johnson \& Johnson Vision) |
| EDOF IOL | – | –Asqelio EDOF ETLIO130C (AST Products) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sex, Ages: 45-75 years, Healthy Volunteers: No
Key inclusion criteria (3 listed)
- Age-related cataract in both eyes
- Eligible for bilateral IOL implantation
- Willingness to return for scheduled follow-up
Key exclusion criteria (5 listed)
- Preoperative corneal astigmatism > 1.0 D
- Axial length >21 mm or <26 mm
- Previous intraocular or corneal surgery
- Ocular comorbidities affecting vision (severe dry eye, amblyopia, ocular surface disease, corneal pathology, retinal diseases, uveitis, glaucoma, pseudoexfoliation, pterygium)
- Intraoperative or postoperative complications, or failure to complete 6-month follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Outcomes
Time frame: 6 months
* Binocular uncorrected distance visual acuity (UDVA) at 6 m, logMAR * Binocular uncorrected intermediate visual acuity (UIVA) at 66 cm, logMAR * Binocular uncorrected near visual acuity (UNVA) at 40 cm, logMAR
Patient satisfaction score
Time frame: postoperative 6 months
The patients were asked about their satisfaction with the refractive outcome, as used in International Multicenter Concerto Study as follows: How satisfied are you with your spectacle-free vision at far/intermediate/near distance? The answer choices ranged from 0 (not at all satisfied) to 10 (very satisfied).
4 secondary outcomes
Visual acuity
Time frame: 6 months
Objective refraction
Time frame: 6 months
Defocus curve
Time frame: 6 months
Photic phenomena
Time frame: 6 months
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Age-related Cataract, run by Sakarya Yenikent State Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 23 Apr 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 Turkey (Türkiye). 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?
Visual Outcomes (time frame: 6 months). The study lists 2 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 23 Apr 2026.