CataractNCT03876782
Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
An observational study of Cataract, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is to evaluate the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- IOLMaster and Verion
- How many people
- 54 participants
- Where
- 1 siteGreece
- Study dates
- 15 Dec 2017to 15 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis
Who may be able to join
- Senile Cataract
Who cannot join
- Former incisional surgery,
- Corneal diseases,
- Dry-eye-Disease,
- Glaucoma drops,
- Inability to obtain accurate measurements.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Primary objective of this study is to evaluate the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation.
Read the detailed description
Participants were enrolled from the Cataract \& Presbyopia Service of the University General Hospital of Alexandroupolis in a consecutive-if-eligible basis. Apart from keratometric values, IOL power calculations will be compared for 8 IOL models (Acrysof SN60WF, SN60AT, SN6ATx, TFNT00, TFNTx0, SV25T0, SV25Tx and Tecnis ZCB00) using 4 formulas (SRK/T, Holladay 1, Hoffer Q and Haigis).
- Conditions
- Cataract
- Being tested
- IOLMaster, Verion
- Keywords
- cataract surgery, Verion Image-Guided System, IOLMaster, IOL calculation, keratometry, corneal power, toric IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMasterDiagnostic test
IOL power calculation will be done with IOLMaster
VerionDiagnostic test
IOL power calculation will be done with Verion
| Study group | Role | What they receive |
|---|---|---|
| IOLMaster group | IOL power for all cataract participants will be measured with IOLMaster and Verion Receives: Diagnostic Test: IOLMaster; Diagnostic Test: Verion |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL Power Calculation
Exact calculation of dioptric power of the intraocular lens
Measured: 1 day prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start15 Dec 2017
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 54 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, MD, PhD, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876782
- Sponsor's protocol ID
- Th9/ES2/22-2-19
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
- ClinicalTrials.gov ID
- NCT03876782
- Acronym / sponsor ID
- Th9/ES2/22-2-19
- Conditions
- Cataract
- Keywords
- cataract surgery, Verion Image-Guided System, IOLMaster, IOL calculation, keratometry, corneal power, toric IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 15 Mar 2019 (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 the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation.
Detailed description
Participants were enrolled from the Cataract \& Presbyopia Service of the University General Hospital of Alexandroupolis in a consecutive-if-eligible basis. Apart from keratometric values, IOL power calculations will be compared for 8 IOL models (Acrysof SN60WF, SN60AT, SN6ATx, TFNT00, TFNTx0, SV25T0, SV25Tx and Tecnis ZCB00) using 4 formulas (SRK/T, Holladay 1, Hoffer Q and Haigis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOLMaster group | – | Diagnostic Test: IOLMaster, Diagnostic Test: VerionIOL power for all cataract participants will be measured with IOLMaster and Verion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis
Key inclusion criteria (1 listed)
- Senile Cataract
Key exclusion criteria (5 listed)
- Former incisional surgery,
- Corneal diseases,
- Dry-eye-Disease,
- Glaucoma drops,
- Inability to obtain accurate measurements.
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 |
|---|---|---|
| IOLMasterIOL power calculation will be done with IOLMaster | Diagnostic test | IOLMaster group |
| VerionIOL power calculation will be done with Verion | Diagnostic test | IOLMaster group |
Primary outcome
IOL Power Calculation
Time frame: 1 day prior to surgery
Exact calculation of dioptric power of the intraocular lens
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 15 Mar 2019.
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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 Cataract, 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 5 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 15 Mar 2019. 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?
IOL Power Calculation (time frame: 1 day prior to surgery). 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 15 Mar 2019.