HealthyNCT06358456
Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices
A study testing Artificial tear and No artificial tears in people with Healthy, run by University Clinic Frankfurt at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are: Do artificial tears alter the measurements of the corneal surface Is there a difference between the devices used in this study This… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Artificial tear and No artificial tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2020to 22 Apr 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy eyes
Who cannot join
- Any prior intraocular surgery or trauma
- Any corneal pathology (ABMD, Fuch's, etc.)
- Active ocular pathology (e.g., amblyopia, ARMD)
- Contact lens wear within 2 weeks of study
- Any corneal relaxing incisions or astigmatic keratotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology
The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
- Do artificial tears alter the measurements of the corneal surface
- Is there a difference between the devices used in this study
This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
- Conditions
- Healthy
- Being tested
- Artificial tear, No artificial tears
- Keywords
- artificial tears, keratometry, topography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial tearDrug
Also called Artelac EDO
Application of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container).
No artificial tearsOther
Before artificial tear application, 2 baseline measurements were taken of the cornea without any intervention
| Study group | Role | What they receive |
|---|---|---|
| IOL Master 700 | Active comparator | Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements Receives: Drug: Artificial tear; Other: No artificial tears |
| Pentacam AXL | Active comparator | Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements Receives: Drug: Artificial tear; Other: No artificial tears |
| Galilei G6 | Active comparator | Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements Receives: Drug: Artificial tear; Other: No artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6)
Measured: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Secondary outcomes (3)
Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?
Difference of measurement of the mean corneal refractive power in diopters before artificial tear (Artelac EDO) application and after artificial tear application between the three devices (IOL Master 700 using Keratometry, Pentacam AXL and Galilei G6 using Schmeipflug technology)
Measured: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
Difference of measurement of the mean corneal astigmatism in diopters before artificial tear (Artelac EDO) application and after artificial tear application using three different devices (IOL Master 700, Pentacam AXL and Galilei G6)
Measured: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?
How long does the difference of mean corneal refractive power in diopters before artificial tear (artelac ego) application and after artificial tear application last
Measured: Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start20 Nov 2020
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
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 HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one arm for each diagnostic device (three in total)
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358456
- Sponsor's protocol ID
- 20-928
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.
PubMed 32828877
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology
- ClinicalTrials.gov ID
- NCT06358456
- Acronym / sponsor ID
- 20-928
- Conditions
- Healthy
- Keywords
- artificial tears, keratometry, topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 10 Apr 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 goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
- Do artificial tears alter the measurements of the corneal surface
- Is there a difference between the devices used in this study
This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- one arm for each diagnostic device (three in total)
| Arm | Type | Receives |
|---|---|---|
| IOL Master 700 | Active comparator | Drug: Artificial tear, Other: No artificial tearsPatients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements |
| Pentacam AXL | Active comparator | Drug: Artificial tear, Other: No artificial tearsPatients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements |
| Galilei G6 | Active comparator | Drug: Artificial tear, Other: No artificial tearsPatients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy eyes
Key exclusion criteria (5 listed)
- Any prior intraocular surgery or trauma
- Any corneal pathology (ABMD, Fuch's, etc.)
- Active ocular pathology (e.g., amblyopia, ARMD)
- Contact lens wear within 2 weeks of study
- Any corneal relaxing incisions or astigmatic keratotomy
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 |
|---|---|---|
| Artificial tearAlso: Artelac EDOApplication of low viscosity artificial tears (Artelac EDO). The active ingredient is hypromellose (1.92 mg per 0.6 ml container). | Drug | Galilei G6, IOL Master 700, Pentacam AXL |
| No artificial tearsBefore artificial tear application, 2 baseline measurements were taken of the cornea without any intervention | Other | Galilei G6, IOL Master 700, Pentacam AXL |
Primary outcome
Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6)
3 secondary outcomes
Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?
Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
Time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?
Time frame: Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications
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 10 Apr 2024.
- Background: PubMed 32828877Roggla V, Leydolt C, Schartmuller D, Schwarzenbacher L, Meyer E, Abela-Formanek C, Menapace R. Influence of Artificial Tears on Keratometric Measurements in Cataract Patients. Am J Ophthalmol. 2021 Jan;221:1-8. doi: 10.1016/j.ajo.2020.08.024. Epub 2020 Aug 21.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial tear and No artificial tears in people with Healthy, run by University Clinic Frankfurt at 1 site in Germany.
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 10 Apr 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 Germany. 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?
Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) (time frame: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application). 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 NCT06358456, 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 10 Apr 2024.