Corneal Sensation ReducedNCT04384094
Defining the Operating Parameters for a Rebound-esthesiometer
An observational study of Corneal Sensation Reduced and Corneal Dystrophy, run by Icare Finland Oy.
Trial summary
The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Sensation Reduced, Corneal Dystrophy, Corneal Degeneration
- What is being tested?
- Esthesiometer measurement
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.
Who may be able to join
- Age >= 18
- Informed consent signed
Who cannot join
- Signs of infectious or inflammatory disease of anterior eye at the time of presentation.
- During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.
- Unable to give informed consent.
- Directly or indirectly indicated vunerability.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Rebound Esthesiometer Phase 2 Protocol
The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.
Read the detailed description
Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.
In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.
- Conditions
- Corneal Sensation Reduced, Corneal Dystrophy, Corneal Degeneration, Corneal Transplant Failure, Herpetic Keratitis
- Being tested
- Esthesiometer measurement
- Keywords
- esthesiometry, corneal sensitivity
- Medical subject headings
- Corneal Dystrophies, Hereditary, Keratitis, Herpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esthesiometer measurementDevice
Measuring the corneal sensitivity using rebound technology.
| Study group | Role | What they receive |
|---|---|---|
| Test subjects | Test subjects according to the inclusion / exclusion criterias. Receives: Device: Esthesiometer measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound esthesiometer operating threshold
Define the corneal touch sensitivity threshold using the rebound esthesiometer by varying the measurement probe impact at the moment of touch of corneal surface. The impact is varied by changing the speed (m/s) of the measurement probe and the subjective sensation of the test subject is recorded. The mass (mg) of the measurement probe is known and the impact energy is calculated.
Measured: 2020-2021
Rebound esthesiometer operating parameters
Measure the correlation of corneal touch sensitivity between rebound esthesiometer and the reference instrument Cochet-Bonnet monofilament esthesiometer. With the rebound esthesiometer the impact is varied by changing the speed (m/s) of the measurement probe. The probe mass (mg) and speed (m/s) equals to the touch impact impulse which causes the touch sensation. The subjective sensation of the test subject is recorded.
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Sensation ReducedStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icare Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matjaz Mihelcic, Ph.D., Principal investigator, Optika Mesec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384094
- Sponsor's protocol ID
- TE0X_EST_2
- Status last verified
- Apr 2020
- First submitted
- 4 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Esthesiometer Phase 2 Protocol
- ClinicalTrials.gov ID
- NCT04384094
- Acronym / sponsor ID
- TE0X_EST_2
- Conditions
- Corneal Sensation Reduced, Corneal Dystrophy, Corneal Degeneration, Corneal Transplant Failure, Herpetic Keratitis
- Keywords
- esthesiometry, corneal sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Icare Finland OyIndustry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 May 2020 (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 purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.
Detailed description
Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.
In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test subjects | – | Device: Esthesiometer measurementTest subjects according to the inclusion / exclusion criterias. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.
Key inclusion criteria (2 listed)
- Age >= 18
- Informed consent signed
Key exclusion criteria (4 listed)
- Signs of infectious or inflammatory disease of anterior eye at the time of presentation.
- During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.
- Unable to give informed consent.
- Directly or indirectly indicated vunerability.
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 |
|---|---|---|
| Esthesiometer measurementMeasuring the corneal sensitivity using rebound technology. | Device | Test subjects |
Primary outcome
Rebound esthesiometer operating threshold
Time frame: 2020-2021
Define the corneal touch sensitivity threshold using the rebound esthesiometer by varying the measurement probe impact at the moment of touch of corneal surface. The impact is varied by changing the speed (m/s) of the measurement probe and the subjective sensation of the test subject is recorded. The mass (mg) of the measurement probe is known and the impact energy is calculated.
Rebound esthesiometer operating parameters
Time frame: 2020-2021
Measure the correlation of corneal touch sensitivity between rebound esthesiometer and the reference instrument Cochet-Bonnet monofilament esthesiometer. With the rebound esthesiometer the impact is varied by changing the speed (m/s) of the measurement probe. The probe mass (mg) and speed (m/s) equals to the touch impact impulse which causes the touch sensation. The subjective sensation of the test subject is recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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.
Matjaz Mihelcic, Ph.D. principal investigator
Optika Mesec
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Sensation Reduced and Corneal Dystrophy, run by Icare Finland Oy.
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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mika Salkola, M.Sc. (+358400874054, mika.salkola@icarefinland.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebound esthesiometer operating threshold (time frame: 2020-2021). The study lists 2 primary outcomes in all. 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 Jul 2020.