PresbyopiaNCT05494177
Comparison of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
An observational study of Presbyopia and Refractive Errors, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Presbyopia, Refractive Errors, Cataract
- What is being tested?
- bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS and Contrast sensitivity
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Aug 2022to 1 Mar 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were examined at the outpatient of the Department of Ophthalmology of the University General Hospital of Alexandroupolis with the diagnosis of cataract with stage 2 (according to LOCS III) and underwent one of the following presbyopia correction surguries: 1. Bilateral implantation of trifocal diffractive intraocular lenses 2. Premium monovision with implantation of an extended depth of focus intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye
Who may be able to join
- Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
- Age>45 years
Who cannot join
- Disability to understand the Greek language and respond to the interview
- Fundus or corneal diseases
- 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: Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.
Read the detailed description
Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.
- Conditions
- Presbyopia, Refractive Errors, Cataract
- Being tested
- bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS, Contrast sensitivity
- Keywords
- pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses
- Medical subject headings
- Presbyopia, Refractive Errors, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bUDVA, bUIRA, bUNRA, bUICPS, bUNCPSDiagnostic test
All participants will be assessed on the following clinical indexes:
- Binocular uncorrected distant visual acuity (bUDVA) at four meters distance
- Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm
- Binocular uncorrected near reading acuity (bUNVA) at 40 cm
- Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm
- Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm
All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART).
Contrast sensitivityDiagnostic test
Contrast sensitivity is assessed with the Pelli-Robson test.
| Study group | Role | What they receive |
|---|---|---|
| Premium monovision | Patients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye. Receives: Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity | |
| Bilateral trifocal diffractive implantation | Patients will undergo to bilateral implantation of trifocal diffractive lenses. Receives: Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS; Diagnostic Test: Contrast sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected distant visual acuity (bUDVA)
bUDVA is obtained using the distance vision test of DDART at four meters distance.
Measured: 1 year
Binocular uncorrected intermediate reading acuity (bUIRA)
bUIRA is obtained using the near vision test of DDART at 60 cm distance.
Measured: 1 year
Binocular uncorrected near reading acuity (bUNRA)
bUNRA is obtained using the near vision test of DDART at 40 cm distance.
Measured: 1 year
Binocular uncorrected intermediate critical print size (bUICPS)
bUICPS is obtained using the near vision test of DDART at 60 cm distance.
Measured: 1 year
Binocular uncorrected near critical print size (bUNCPS)
bUNCPS is obtained using the near vision test of DDART at 40 cm distance.
Measured: 1 year
Secondary outcomes (4)
Dysphotopsia symptoms
Dysphotopsia is evaluated with two direct 4-scale, Likert-type questions (Always, Most of the times, Sometimes, Never) assessing subjective appearance of glare and halos.
Measured: 1 year
Contrast sensitivity
Contrast sensitivity is evaluated with the Pelli-Robson test.
Measured: 1 year
Spectacle independence
Spectacle dependence is assessed for both distant and near vision by two direct 4-scale Likert-type questions (Always, Most of the times, Sometimes, Never).
Measured: 1 year
Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)
Subjective satisfaction rates are assessed using the prevalent VF-14 questionnaire. Further to the total VF-14 score assessment, two additional scores are calculated: a) Near vision VF score (VF14-NV) derived from items that assess the perceived difficulty in near vision activities (items 1,2,3,7,8,9 and 11), and, b) Distant vision VF score (VF14-DV) derived from items that assess the perceived difficulty of distant vision activities (items 4, 5, 6, 10, 12, 13 and 14).
VF-14 has a final score from 0 to 100. A score of 100 indicates able to do all applicable activities. A score of 0 indicates unable to do all applicable activities because of vision.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
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, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494177
- Sponsor's protocol ID
- ES13/Th7/07-07-2022
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
- ClinicalTrials.gov ID
- NCT05494177
- Acronym / sponsor ID
- ES13/Th7/07-07-2022
- Conditions
- Presbyopia, Refractive Errors, Cataract
- Keywords
- pseudophakic presbyopic correction, premium monovision, trifocal diffractive intraocular lenses, extended depth of field intraocular lenses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 9 Aug 2022 (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 compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.
Detailed description
Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premium monovision | – | Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS, Diagnostic Test: Contrast sensitivityPatients will undergo to implantation of an extended depth of field intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye. |
| Bilateral trifocal diffractive implantation | – | Diagnostic Test: bUDVA, bUIRA, bUNRA, bUICPS, bUNCPS, Diagnostic Test: Contrast sensitivityPatients will undergo to bilateral implantation of trifocal diffractive lenses. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were examined at the outpatient of the Department of Ophthalmology of the University General Hospital of Alexandroupolis with the diagnosis of cataract with stage 2 (according to LOCS III) and underwent one of the following presbyopia correction surguries: 1. Bilateral implantation of trifocal diffractive intraocular lenses 2. Premium monovision with implantation of an extended depth of focus intraocular lens in the dominant eye and a trifocal diffractive intraocular lens in the non-dominant eye
Key inclusion criteria (2 listed)
- Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
- Age>45 years
Key exclusion criteria (4 listed)
- Disability to understand the Greek language and respond to the interview
- Fundus or corneal diseases
- 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 |
|---|---|---|
| bUDVA, bUIRA, bUNRA, bUICPS, bUNCPSAll participants will be assessed on the following clinical indexes: 1. Binocular uncorrected distant visual acuity (bUDVA) at four meters distance 2. Binocular uncorrected intermediate reading acuity (bUIRA) at 60 cm 3. Binocular uncorrected near reading acuity (bUNVA) at 40 cm 4. Binocular uncorrected intermediate Critical Print Size (bUICPS) at 60 cm 5. Binocular uncorrected near Critical Print Size (bUNCPS) at 40 cm All the above parameters are obtained using the Democritus Digital Acuity \& Reading Test (DDART). | Diagnostic test | Bilateral trifocal diffractive implantation, Premium monovision |
| Contrast sensitivityContrast sensitivity is assessed with the Pelli-Robson test. | Diagnostic test | Bilateral trifocal diffractive implantation, Premium monovision |
Primary outcome
Binocular uncorrected distant visual acuity (bUDVA)
Time frame: 1 year
bUDVA is obtained using the distance vision test of DDART at four meters distance.
Binocular uncorrected intermediate reading acuity (bUIRA)
Time frame: 1 year
bUIRA is obtained using the near vision test of DDART at 60 cm distance.
Binocular uncorrected near reading acuity (bUNRA)
Time frame: 1 year
bUNRA is obtained using the near vision test of DDART at 40 cm distance.
Binocular uncorrected intermediate critical print size (bUICPS)
Time frame: 1 year
bUICPS is obtained using the near vision test of DDART at 60 cm distance.
Binocular uncorrected near critical print size (bUNCPS)
Time frame: 1 year
bUNCPS is obtained using the near vision test of DDART at 40 cm distance.
4 secondary outcomes
Dysphotopsia symptoms
Time frame: 1 year
Contrast sensitivity
Time frame: 1 year
Spectacle independence
Time frame: 1 year
Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)
Time frame: 1 year
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 18 Jun 2023.
- Derived from this study: 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, MD, PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
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 Refractive Errors, 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 18 Jun 2023. 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?
Binocular uncorrected distant visual acuity (bUDVA) (time frame: 1 year). The study lists 5 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 NCT05494177, 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 18 Jun 2023.