CataractNCT05411341
Comparison of Two Different Optical Biometric Systems
An observational study of Cataract and Presbyopia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia, Ocular Biometry
- What is being tested?
- Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG)
- Type of treatment
- Medical device
- How many people
- 133 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2023to 31 May 2024
- How long will I take part?
- 1 Year
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with cataract and/or presbyopia.
Who may be able to join
- Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.
Who cannot join
- Dense cataract that does not allow measurements to be taken with an optical biometrics system.
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: Assessment of Two Different Optical Biometric Systems, Based on Different Optical Technologies in Patients With Cataract or Presbyopia
Primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).
Read the detailed description
This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white [WTW]) and the lens power in diopters (D).
- Conditions
- Cataract, Presbyopia, Ocular Biometry, Intraocular Lens
- Being tested
- Argos (Alcon Laboratories, Inc.), IOLMaster 500 (Carl Zeiss Meditec AG)
- Keywords
- cataract, presbyopia, argos, iol master 500, optical biometric system
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argos (Alcon Laboratories, Inc.)Device
An ocular biometry examination will be performed on the affected eyes using the Argos device.
IOLMaster 500 (Carl Zeiss Meditec AG)Device
An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery Receives: Device: Argos (Alcon Laboratories, Inc.); Device: IOLMaster 500 (Carl Zeiss Meditec AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
The measurement of the axial length of the affected eye using both devices
Measured: 1 week
Keratometry values
The measurement of keratometry values K1: flat meridian of the anterior corneal surface and K2: steep meridian of the anterior corneal surface of the affected eye using both devices.
Measured: 1 week
Lens power (D)
The power of the lens is calculated by each device as a function of biometric measurements
Measured: 1 week
Secondary outcomes (2)
Anterior chamber depth (ACD)
The measurement of the anterior chamber depth (ACD) of the affected eye using both devices.
Measured: 1 week
Horizontal corneal diameter (white to white [WTW])
The measurement of the horizontal corneal diameter of the affected eye using both devices.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jul 2023
- Primary completion30 Apr 2024
- Study completion31 May 2024
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 CataractStudies 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
- 133 participants (actual)
- Target duration
- 1 Year
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
- NCT05411341
- Sponsor's protocol ID
- ES9/Th3/05-05-2022
- Status last verified
- Feb 2026
- First submitted
- 6 Jun 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Panagiotopoulou EK, Polychroniadis T, Bakirtzis M, Tsinopoulos I, Ziakas N, Labiris G. Level of Agreement of Intraocular Lens Power Measurements Between a Swept-Source OCT Biometer and a Partial Coherence Interferometer. J Clin Med. 2025 Jun 2;14(11):3903. doi: 10.3390/jcm14113903.
PubMed 40507667
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
- Assessment of Two Different Optical Biometric Systems, Based on Different Optical Technologies in Patients With Cataract or Presbyopia
- ClinicalTrials.gov ID
- NCT05411341
- Acronym / sponsor ID
- ES9/Th3/05-05-2022
- Conditions
- Cataract, Presbyopia, Ocular Biometry, Intraocular Lens
- Keywords
- cataract, presbyopia, argos, iol master 500, optical biometric system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 9 Jun 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 evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (IOL-PC).
Detailed description
This is a prospective study including patients visiting the outpatient Ophthalmology clinic of the University General Hospital of Alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. The patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. They will then undergo an ocular biometry examination using two optical biometric systems, Argos (Alcon Laboratories, Inc.) and IOLMaster 500 (Carl Zeiss Meditec AG). IOL Master 500 (Carl Zeiss Meditec AG) is a non-invasive optical biometer that uses partial coherence interferometry (PCI) with a wavelength of 780 nm to measure the AL of the eye. Argos (Alcon Laboratories, Inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (SS-OCT) with a wavelength of 1050 nm. The measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (ACD), the horizontal corneal diameter (white to white [WTW]) and the lens power in diopters (D).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Argos (Alcon Laboratories, Inc.), Device: IOLMaster 500 (Carl Zeiss Meditec AG)100 patients with diagnosed cataract or presbyopia who will undergo implantation of intraocular lenses surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cataract and/or presbyopia.
Key inclusion criteria (1 listed)
- Patients with cataract and/or presbyopia who will undergo intraocular lens implantation.
Key exclusion criteria (1 listed)
- Dense cataract that does not allow measurements to be taken with an optical biometrics system.
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 |
|---|---|---|
| Argos (Alcon Laboratories, Inc.)An ocular biometry examination will be performed on the affected eyes using the Argos device. | Device | Study Group |
| IOLMaster 500 (Carl Zeiss Meditec AG)An ocular biometry examination will be performed on the affected eyes using the IOL Master 500 device. | Device | Study Group |
Primary outcome
Axial length
Time frame: 1 week
The measurement of the axial length of the affected eye using both devices
Keratometry values
Time frame: 1 week
The measurement of keratometry values K1: flat meridian of the anterior corneal surface and K2: steep meridian of the anterior corneal surface of the affected eye using both devices.
Lens power (D)
Time frame: 1 week
The power of the lens is calculated by each device as a function of biometric measurements
2 secondary outcomes
Anterior chamber depth (ACD)
Time frame: 1 week
Horizontal corneal diameter (white to white [WTW])
Time frame: 1 week
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.
- Results publication: PubMed 40507667Panagiotopoulou EK, Polychroniadis T, Bakirtzis M, Tsinopoulos I, Ziakas N, Labiris G. Level of Agreement of Intraocular Lens Power Measurements Between a Swept-Source OCT Biometer and a Partial Coherence Interferometer. J Clin Med. 2025 Jun 2;14(11):3903. doi: 10.3390/jcm14113903.
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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 Cataract and 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 1 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?
Axial length (time frame: 1 week). 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?
On the ClinicalTrials.gov record for NCT05411341, 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.