PresbyopiaNCT06460389
Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
An observational study of Presbyopia and Pseudophakia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Pseudophakia, Cataract
- What is being tested?
- Visual Acuity Assessment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants that underwent Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance.
Who may be able to join
- Diagnosis of grade 2 cataracts (according to LOCS III)
- age >45 years.
Who cannot join
- Inability to understand the Greek language and respond to the interview
- conditions of the posterior or corneal segment
- glaucoma
- previous intraocular surgery
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.
Read the detailed description
This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.
In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity \& Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.
- Conditions
- Presbyopia, Pseudophakia, Cataract, Refractive Errors
- Being tested
- Visual Acuity Assessment
- Keywords
- pseudophakic presbyopic correction, extended depth of field intraocular lenses, visual curve, visual acuity
- Medical subject headings
- Presbyopia, Pseudophakia, Cataract, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Acuity AssessmentDiagnostic test
Uncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity \& Reading Test (DDART).
| Study group | Role | What they receive |
|---|---|---|
| Insertion of an extended depth of focus intraocular lens with digital assistance | Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance Receives: Diagnostic Test: Visual Acuity Assessment | |
| Insertion of an extended depth of focus intraocular lens without digital assistance | Participants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance Receives: Diagnostic Test: Visual Acuity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity assessment
Visual acuity assessment in 9 focal points using DDART chart
Measured: 4 months
Area of the curve (AOC) assessment
Calculation of the AOC as a visual outscome measure
Measured: 4 months
the degree of subjective satisfaction of the patient
the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2024
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
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, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460389
- Sponsor's protocol ID
- ES6/Th11/14-03-2024
- Status last verified
- Feb 2026
- First submitted
- 11 Jun 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance
- ClinicalTrials.gov ID
- NCT06460389
- Acronym / sponsor ID
- ES6/Th11/14-03-2024
- Conditions
- Presbyopia, Pseudophakia, Cataract, Refractive Errors
- Keywords
- pseudophakic presbyopic correction, extended depth of field intraocular lenses, visual curve, visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jun 2024 (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 compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.
Detailed description
This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.
In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity \& Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion of an extended depth of focus intraocular lens with digital assistance | – | Diagnostic Test: Visual Acuity AssessmentParticipants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens with digital assistance |
| Insertion of an extended depth of focus intraocular lens without digital assistance | – | Diagnostic Test: Visual Acuity AssessmentParticipants that underwent uncomplicated IOL implantation of an extended depth of focus intraocular lens without digital assistance |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that underwent Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance.
Key inclusion criteria (2 listed)
- Diagnosis of grade 2 cataracts (according to LOCS III)
- age >45 years.
Key exclusion criteria (4 listed)
- Inability to understand the Greek language and respond to the interview
- conditions of the posterior or corneal segment
- glaucoma
- previous intraocular surgery
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 |
|---|---|---|
| Visual Acuity AssessmentUncorrected visual acuity for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm) examination via a Democritus Digital Acuity \& Reading Test (DDART). | Diagnostic test | Insertion of an extended depth of focus intraocular lens with digital assistance, Insertion of an extended depth of focus intraocular lens without digital assistance |
Primary outcome
Visual acuity assessment
Time frame: 4 months
Visual acuity assessment in 9 focal points using DDART chart
Area of the curve (AOC) assessment
Time frame: 4 months
Calculation of the AOC as a visual outscome measure
the degree of subjective satisfaction of the patient
Time frame: 4 months
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 24 Feb 2026.
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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 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 and Pseudophakia, 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 2 inclusion and 4 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 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?
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 acuity assessment (time frame: 4 months). 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?
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.