PresbyopiaV(λ)'_EDOFNCT07077967
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
An observational study of Presbyopia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Phacoemulsification with EDOF IOLs
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 15 Oct 2025to 15 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Presbyopic patients who underwent pseudophakic presbyopic correction with EDOF intraocular lens implantation
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. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Dimitrios Aggelonias, MSc, +30 2551030990, dangelon@affil.duth.gr
Eirini - Kanella Panagiotopoulou, panagiotopoulou.ek@gmail.com
About this study
Official title: Impact of Artificial Lighting on Visual Acuity After Presbyopia Correction With an Extended Depth of Focus Intraocular Lens: Introduction of a Modified Luminous Efficiency Function V(λ)'
Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.
Read the detailed description
Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)
- Conditions
- Presbyopia
- Being tested
- Phacoemulsification with EDOF IOLs
- Keywords
- pseudophakic presbyopic correction, EDOF intraocular lens, light intensity, eye light transmittance, light efficiency function
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with EDOF IOLsProcedure or surgery
Uneventful pseudophakic presbyopic correction with EDOF IOLs
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA) Receives: Procedure: Phacoemulsification with EDOF IOLs | |
| Control group | Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Required Illuminance Level (MRIL)
Minimum Required Illuminance Level (MRIL) (in lx) at which participants reach their optimal Uncorrected Distance Visual Acuity.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 100 participants (estimated)
- Target duration
- 6 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, MD, Prof, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077967
- Sponsor's protocol ID
- ES5/Th9/13-02-2025
- Acronym
- V(λ)'_EDOF
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
PubMed 34866900
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Artificial Lighting on Visual Acuity After Presbyopia Correction With an Extended Depth of Focus Intraocular Lens: Introduction of a Modified Luminous Efficiency Function V(λ)'
- ClinicalTrials.gov ID
- NCT07077967
- Acronym / sponsor ID
- V(λ)'_EDOF / ES5/Th9/13-02-2025
- Conditions
- Presbyopia
- Keywords
- pseudophakic presbyopic correction, EDOF intraocular lens, light intensity, eye light transmittance, light efficiency function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.
Detailed description
Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Phacoemulsification with EDOF IOLsPatients who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA) |
| Control group | – | –Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Presbyopic patients who underwent pseudophakic presbyopic correction with EDOF intraocular lens implantation
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 EDOF IOLsUneventful pseudophakic presbyopic correction with EDOF IOLs | Procedure or surgery | Study group |
Primary outcome
Minimum Required Illuminance Level (MRIL)
Time frame: 6 months postoperatively
Minimum Required Illuminance Level (MRIL) (in lx) at which participants reach their optimal Uncorrected Distance Visual Acuity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: PubMed 34866900Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.
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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.
Georgios Labiris, MD, Prof study chair
Democritus University of Thrace
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, 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: looking for participants now, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eirini - Kanella Panagiotopoulou, MD, MSc, PhD (+30 6978730858, panagiotopoulou.ek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum Required Illuminance Level (MRIL) (time frame: 6 months postoperatively). 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 NCT07077967, which also lists 1 linked publication.
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 24 Feb 2026.