PresbyopiaNCT06260852
Identification of Minimum Focal Points in Vision Curve Formation
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 identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Pseudophakia, Cataract
- What is being tested?
- Diagnostic Test: Visual Acuity Assessment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2024to Aug 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
Who may be able to join
- age over 40,
- previous bilateral premium cataract surgery,
- best corrected visual acuity (BCVA) < 0,2 logMAR
Who cannot join
- taking topical medication to reduce intraocular pressure (IOP),
- macular diseases,
- corneal diseases,
- inability to understand the procedure,
- postoperative astigmatism >1.50 diopters,
- postoperative clouding of the posterior capsule
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Georgios Labiris, MD, PhD, 00302551030405, labiris@usa.net
About this study
Official title: Identification of Minimum Focal Points in Vision Curve Formation After Pseudophakic Presbyopia Surgery
The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
Read the detailed description
This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.
- Conditions
- Presbyopia, Pseudophakia, Cataract, Refractive Errors
- Being tested
- Diagnostic Test: Visual Acuity Assessment
- Keywords
- pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses
- 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.
Diagnostic Test: 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 |
|---|---|---|
| Premium presbyopia surgery | Participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation Receives: Diagnostic Test: Diagnostic Test: Visual Acuity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual curves interpolation
Visual curves interpolation after visual acuity assessment in 9 focal points
Measured: 6 months
Area of the curve (AOC) assessment
Calculation of the AOC after visual curve interpolation
Measured: 6 months
Visual acuity assessment
Visual acuity assessment in 9 focal points using DDART chart
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 posted15 Feb 2024
- Study start1 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
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
- 80 participants (estimated)
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, PhD, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260852
- Sponsor's protocol ID
- ES20/Th8/23-11-2023
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Minimum Focal Points in Vision Curve Formation After Pseudophakic Presbyopia Surgery
- ClinicalTrials.gov ID
- NCT06260852
- Acronym / sponsor ID
- ES20/Th8/23-11-2023
- Conditions
- Presbyopia, Pseudophakia, Cataract, Refractive Errors
- Keywords
- pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 15 Feb 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 identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.
Detailed description
This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premium presbyopia surgery | – | Diagnostic Test: Diagnostic Test: Visual Acuity AssessmentParticipants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation
Key inclusion criteria (3 listed)
- age over 40,
- previous bilateral premium cataract surgery,
- best corrected visual acuity (BCVA) < 0,2 logMAR
Key exclusion criteria (6 listed)
- taking topical medication to reduce intraocular pressure (IOP),
- macular diseases,
- corneal diseases,
- inability to understand the procedure,
- postoperative astigmatism >1.50 diopters,
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 |
|---|---|---|
| Diagnostic Test: 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 | Premium presbyopia surgery |
Primary outcome
Visual curves interpolation
Time frame: 6 months
Visual curves interpolation after visual acuity assessment in 9 focal points
Area of the curve (AOC) assessment
Time frame: 6 months
Calculation of the AOC after visual curve interpolation
Visual acuity assessment
Time frame: 6 months
Visual acuity assessment in 9 focal points using DDART chart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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, MD, PhD 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Labiris, MD, PhD (00302551030405, labiris@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual curves interpolation (time frame: 6 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 7 Mar 2024.