CataractKerStyNCT04196621
Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
A study testing High viscous artificial tears and Low viscous artificial tears in people with Cataract and Dry Eye, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power. First, two native measurements at the IOL Master will be performed. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- What is being tested?
- High viscous artificial tears and Low viscous artificial tears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 15 Feb 2020
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed uni- or bilateral age-related cataract
- Age 40 to 95
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Corneal abnormality (Corneal scaring)
- usage of artificial tears/eyedrops 24h before the examination
- necessity of any topical therapy of the eye (i.e. glaucoma)
- active ocular or nasal allergies or corneal or conjunctival infection
- abnormality of the nasolacrimal drainage apparatus
- dry eye severity level 4 (severe and/or disabling constant discomfort and visual symptoms, marked conjunctival injection, filamentary keratitis, mucus clumping, tear debris, ulceration, trichiasis, keratinization, symblepharon)
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- lid deformities
- Preceding ocular surgery or trauma
- Pregnancy
- Lactation
- Uncontrolled systemic or ocular disease
Trial locations and contacts
1 site in 1 country.
About this study
The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.
First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
Read more
At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.
- Being tested
- High viscous artificial tears, Low viscous artificial tears
- Medical subject headings
- Cataract, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High viscous artificial tearsDevice
Instillation of one drop high viscous artificial tears
Low viscous artificial tearsDevice
Instillation of one drop low viscous artificial tears
| Study group | Role | What they receive |
|---|---|---|
| High viscous artificial tears | Active comparator | First, a native measurement at the IOL Master will be performed. Following which, high viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes Receives: Device: High viscous artificial tears |
| Low viscous artificial tears | Active comparator | First, a native measurement at the IOL Master will be performed. Following which, low viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes Receives: Device: Low viscous artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds.
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Measured: 30 seconds
Secondary outcomes (3)
To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective.
The change in measured k-values (k, k1, k2 in mm)before and after instillation of artificial eye drops will be calculated
Measured: 2, 5minutes
To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Measured: 30 seconds, 2 minutes or 5 minutes
To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
Measured: 30 seconds, 2 minutes or 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion15 Feb 2020
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196621
- Sponsor's protocol ID
- 2112/2018
- Acronym
- KerSty
- Status last verified
- Apr 2020
- First submitted
- 5 Dec 2019
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Reproducibility of Keratometric Measurements and Influencing Factors in Cataract Patients
- ClinicalTrials.gov ID
- NCT04196621
- Acronym / sponsor ID
- KerSty / 2112/2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 12 Dec 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.
The investigational device is an approved biometry device to perform biometric measurements preoperatively to calculate the needed IOL power.
First, two native measurements at the IOL Master will be performed. Thereafter randomly assigned artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
At least 24hours after those measurements, two native measurements at the IOL Master will be performed. Thereafter, the not yet used artificial tears are instilled in the eye and biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry without and with artificial tear drops.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Biometry will be performed in individuals with age related cataract. Patients will be classified as dry eye or normal eye. Two different artificial tears will be instilled at two time points in a randomized order with a time-lag of at least 24 hours.
| Arm | Type | Receives |
|---|---|---|
| High viscous artificial tears | Active comparator | Device: High viscous artificial tearsFirst, a native measurement at the IOL Master will be performed. Following which, high viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes |
| Low viscous artificial tears | Active comparator | Device: Low viscous artificial tearsFirst, a native measurement at the IOL Master will be performed. Following which, low viscous artificial tears are installed and the biometry will be repeated within 30 seconds, as well as after 2 and 5 minutes |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed uni- or bilateral age-related cataract
- Age 40 to 95
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (11 listed)
- Corneal abnormality (Corneal scaring)
- usage of artificial tears/eyedrops 24h before the examination
- necessity of any topical therapy of the eye (i.e. glaucoma)
- active ocular or nasal allergies or corneal or conjunctival infection
- abnormality of the nasolacrimal drainage apparatus
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 |
|---|---|---|
| High viscous artificial tearsInstillation of one drop high viscous artificial tears | Device | High viscous artificial tears |
| Low viscous artificial tearsInstillation of one drop low viscous artificial tears | Device | Low viscous artificial tears |
Primary outcome
The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds.
Time frame: 30 seconds
The change in measured k-values (k, k1, k2 in mm) before and after instillation of artificial eye drops will be calculated
3 secondary outcomes
To determine whether application of highly viscid eye drops in normal eyes leads to a change keratometry measurements after 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective.
Time frame: 2, 5minutes
To determine whether application of slightly viscid eye drops in normal and in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective
Time frame: 30 seconds, 2 minutes or 5 minutes
To determine whether application of highly viscid eye drops in dry eyes leads to a change in keratometry measurements after 30 seconds, 2 minutes or 5 minutes. These objectives will be assessed analogously to the primary objective
Time frame: 30 seconds, 2 minutes or 5 minutes
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 29 Apr 2020.
- 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 High viscous artificial tears and Low viscous artificial tears in people with Cataract and Dry Eye, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 11 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 29 Apr 2020. 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 Austria. 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?
The primary objective is to determine whether application of highly viscid eye drops in normal eyes leads to a change in keratometry measurements after 30 seconds. (time frame: 30 seconds). 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 29 Apr 2020.