PresbyopiaIOL-VACNCT07439835
Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens
An observational study of Presbyopia and IOL, Cataract, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The primary objective of this study is to evaluate postoperative visual acuity curves in pseudophakic patients following unilateral or bilateral implantation of the enhanced monofocal TECNIS Eyhance IOL, using the DDARTVC. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Presbyopia, IOL, Cataract
- What is being tested?
- Phacoemulsification with enhanced monofocal IOLs
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2024to 15 Dec 2025
- How long will I take part?
- 3 Months
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Presbyopic patients who underwent pseudophakic presbyopic correction with the enhanced monofocal IOL Eyhance
Who may be able to join
- age between 45 to 75 years
Who cannot join
- astigmatism >1.00 diopters
- glaucoma
- former incisional eye surgery
- corneal or fundus disease
- diabetes mellitus
- autoimmune diseases
Show all 9Show fewer
- neurological or psychiatric diseases
- posterior capsule rupture or lens misalignment
- postoperative uncorrected distance visual acuity < 8/10.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100
Alexandroupoli, Evros, 68100
About this study
Official title: Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens: A Prospective Study
The primary objective of this study is to evaluate postoperative visual acuity curves in pseudophakic patients following unilateral or bilateral implantation of the enhanced monofocal TECNIS Eyhance IOL, using the DDARTVC.
Read the detailed description
The present study aims to identify the exact points of the visual acuity curve, in which the enhanced monofocal TECNIS Eyhance IOL exhibit the optimal visual performance. Specifically, the study takes into account that the validated digital acuity chart DDARTVC assesses visual acuity under real-life conditions at nine discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm), rather than through simulated defocus values. Moreover, spline curve fitting was applied to the measured data points to generate continuous visual acuity curves, enabling estimation of visual performance across the full range of distances, rather than only at the predefined measurement points.
- Conditions
- Presbyopia, IOL, Cataract
- Being tested
- Phacoemulsification with enhanced monofocal IOLs
- Keywords
- pseudophakic presbyopic correction, enhanced monofocal intraocular lens, defocus curves, visual curves, digital optotype
- Medical subject headings
- Presbyopia, Intraocular Lymphoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with enhanced monofocal IOLsProcedure or surgery
Uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA)
| Study group | Role | What they receive |
|---|---|---|
| Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation | Patients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA) Receives: Procedure: Phacoemulsification with enhanced monofocal IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity assessment
Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart
Measured: 3 months postoperatively
Area of the Visual Acuity Curve (AoC) assessment
Calculation of the AoC as a visual outcome measure
Measured: 3 months postoperatively
Vision-Related Quality of Life
the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)
Measured: 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 posted27 Feb 2026
- Study start1 Apr 2024
- Primary completion20 Jul 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, Professor, Principal investigator, University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439835
- Sponsor's protocol ID
- ES3/Th5/03-02-2022
- Acronym
- IOL-VAC
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Panagis C, Mitsi C, Panagiotopoulou EK, Vorgiazidou E, Delibasis KK, Bakirtzis M. Enhancing Postoperative Evaluation of Presbyopia Corrections: Correlation of Visual Curve Indices with Vision-Related Quality of Life. J Clin Med. 2025 Oct 10;14(20):7149. doi: 10.3390/jcm14207149.
PubMed 41156017Labiris G, Panagiotopoulou EK, Delibasis K, Duzha E, Bakirtzis M, Panagis C, Boboridis K, Mokka A, Balidis M, Damtsi C, Ntonti P. Validation of a web-based distance visual acuity test. J Cataract Refract Surg. 2023 Jul 1;49(7):666-671. doi: 10.1097/j.jcrs.0000000000001176.
PubMed 36853857Labiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336.
PubMed 37847127
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Visual Acuity Curves of an Enhanced Monofocal Intraocular Lens: A Prospective Study
- ClinicalTrials.gov ID
- NCT07439835
- Acronym / sponsor ID
- IOL-VAC / ES3/Th5/03-02-2022
- Conditions
- Presbyopia, IOL, Cataract
- Keywords
- pseudophakic presbyopic correction, enhanced monofocal intraocular lens, defocus curves, visual curves, digital optotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 27 Feb 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.
The primary objective of this study is to evaluate postoperative visual acuity curves in pseudophakic patients following unilateral or bilateral implantation of the enhanced monofocal TECNIS Eyhance IOL, using the DDARTVC.
Detailed description
The present study aims to identify the exact points of the visual acuity curve, in which the enhanced monofocal TECNIS Eyhance IOL exhibit the optimal visual performance. Specifically, the study takes into account that the validated digital acuity chart DDARTVC assesses visual acuity under real-life conditions at nine discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm), rather than through simulated defocus values. Moreover, spline curve fitting was applied to the measured data points to generate continuous visual acuity curves, enabling estimation of visual performance across the full range of distances, rather than only at the predefined measurement points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation | – | Procedure: Phacoemulsification with enhanced monofocal IOLsPatients who underwent uneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Presbyopic patients who underwent pseudophakic presbyopic correction with the enhanced monofocal IOL Eyhance
Key inclusion criteria (1 listed)
- age between 45 to 75 years
Key exclusion criteria (9 listed)
- astigmatism >1.00 diopters
- glaucoma
- former incisional eye surgery
- corneal or fundus disease
- diabetes mellitus
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 |
|---|---|---|
| Phacoemulsification with enhanced monofocal IOLsUneventful pseudophakic presbyopic correction with the enhanced monofocal IOL TECNIS® Eyhance ICB00 (Johnson \& Johnson Vision, USA) | Procedure or surgery | Pseuophakic patients with enhanced monofocal IOL bilateral or unilateral implantation |
Primary outcome
Uncorrected Visual Acuity assessment
Time frame: 3 months postoperatively
Visual acuity assessment in 9 discrete distances (25, 28, 33, 40, 50, 60, 100, 200, and 300 cm) using the DDARTVC chart
Area of the Visual Acuity Curve (AoC) assessment
Time frame: 3 months postoperatively
Calculation of the AoC as a visual outcome measure
Vision-Related Quality of Life
Time frame: 3 months postoperatively
the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)
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 27 Feb 2026.
- Background: PubMed 41156017Labiris G, Panagis C, Mitsi C, Panagiotopoulou EK, Vorgiazidou E, Delibasis KK, Bakirtzis M. Enhancing Postoperative Evaluation of Presbyopia Corrections: Correlation of Visual Curve Indices with Vision-Related Quality of Life. J Clin Med. 2025 Oct 10;14(20):7149. doi: 10.3390/jcm14207149.
- Background: PubMed 36853857Labiris G, Panagiotopoulou EK, Delibasis K, Duzha E, Bakirtzis M, Panagis C, Boboridis K, Mokka A, Balidis M, Damtsi C, Ntonti P. Validation of a web-based distance visual acuity test. J Cataract Refract Surg. 2023 Jul 1;49(7):666-671. doi: 10.1097/j.jcrs.0000000000001176.
- Background: PubMed 37847127Labiris G, Panagis C, Ntonti P, Konstantinidis A, Bakirtzis M. Mix-and-match vs bilateral trifocal and bilateral EDOF intraocular lens implantation: the spline curve battle. J Cataract Refract Surg. 2024 Feb 1;50(2):167-173. doi: 10.1097/j.jcrs.0000000000001336.
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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.
Georgios Labiris, Professor principal investigator
University Hospital of Alexandroupolis, Alexandroupolis, Evros 68100
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 Presbyopia and IOL, Cataract, run by Democritus University of Thrace at 1 site in Greece.
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 1 inclusion and 9 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 27 Feb 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 Greece. 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?
Uncorrected Visual Acuity assessment (time frame: 3 months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07439835, which also lists 3 linked publications.
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 27 Feb 2026.