PresbyopiaNCT04263636
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections
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 construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Phacoemulsification with bilateral trifocal diffractive IOLs
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jan 2020to 31 Dec 2020
- How long will I take part?
- 6 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral trifocal intraocular lenses implantation
Who may be able to join
- age between 45 to 70 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 bilateral distant visual acuity < 8/10.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections
Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.
Read the detailed description
Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)
- Conditions
- Presbyopia
- Being tested
- Phacoemulsification with bilateral trifocal diffractive IOLs
- Keywords
- pseudophakic presbyopic correction, trifocal 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 bilateral trifocal diffractive IOLsProcedure or surgery
Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA) Receives: Procedure: Phacoemulsification with bilateral trifocal diffractive IOLs | |
| Control group | Patients of similar age without cataract that their crystalline lens has not been replaced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum light intensity
Minimum light intensity in which participants reach their maximum critical visual acuity
Measured: 6 months postoperatively
Secondary outcomes (1)
Critical Visual Acuity (CVA)
The print size of the optotype line fulfilling this criterion: all of the following lines are read at a time that is 1.96 times the standard deviation over the average reading time of the larger preceding lines. In clinical practice, the CVA is the minimum VA that can be read with the maximum possible speed.
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 posted11 Feb 2020
- Study start7 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 (actual)
- 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, PhD, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263636
- Sponsor's protocol ID
- ES11/Th12/27-12-2019
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections
- ClinicalTrials.gov ID
- NCT04263636
- Acronym / sponsor ID
- ES11/Th12/27-12-2019
- Conditions
- Presbyopia
- Keywords
- pseudophakic presbyopic correction, trifocal intraocular lens, light intensity, eye light transmittance, light efficiency function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Feb 2020 (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 construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.
Detailed description
Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal 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 bilateral trifocal diffractive IOLsPatients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA) |
| Control group | – | –Patients of similar age without cataract that their crystalline lens has not been replaced. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral trifocal intraocular lenses implantation
Key inclusion criteria (1 listed)
- age between 45 to 70 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 bilateral trifocal diffractive IOLsUneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs | Procedure or surgery | Study group |
Primary outcome
Minimum light intensity
Time frame: 6 months postoperatively
Minimum light intensity in which participants reach their maximum critical visual acuity
1 secondary outcome
Critical Visual Acuity (CVA)
Time frame: 6 months postoperatively
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 30 Mar 2021.
- Derived from this study: 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. This study is not recruiting at the moment.
Georgios Labiris, MD, PhD study chair
Associate Professor
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: finished, as of the sponsor's last update on 30 Mar 2021. 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?
Minimum light intensity (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 NCT04263636, 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 30 Mar 2021.