Evaluation of Corneal Stability Post-applanationNCT03275142
Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining
A study testing Icare tonometer in people with Evaluation of Corneal Stability Post-applanation, run by Comprehensive EyeCare of Central Ohio at 1 site in United States.
Trial summary
To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Corneal Stability Post-applanation
- What is being tested?
- Icare tonometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 31 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, 43082
About this study
To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.
Read the detailed description
Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.
- Being tested
- Icare tonometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icare tonometerDevice
Also called Icare, applanation, tonometry
Icare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale.
| Study group | Role | What they receive |
|---|---|---|
| Icare Applanation | Experimental | Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation. Receives: Device: Icare tonometer |
| No ICare Applanation | Active comparator | Evaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation. Receives: Device: Icare tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of corneal stability post-applanation with the Icare tonometer.
Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale
Measured: 30 minutes
Secondary outcomes (3)
Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.
Evaluation of average keratometric difference pre and post-tonometry with ICare via Pentacam HR and IOL Master.
Measured: 10 minutes
Total cylinder differences pre and post-tonometry with ICare tonometer.
Total cylinder differences pre and post-tonometry with ICare Tonometer via Pentacam HR and IOL Master.
Measured: 10 minutes
Difference in corneal staining pre and post-tonometry with ICare Tonometer.
Difference in corneal staining pre and post-tonometry with ICare Tonometer as compared to the Oxford Scoring Scale.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start19 Jun 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Corneal Stability Post-applanationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comprehensive EyeCare of Central Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Icare USA
- Responsible party
- Sponsor
- Investigators
- Kenneth A Beckman, M.D., Study director, Comprehensive EyeCare of Central Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275142
- Sponsor's protocol ID
- 170608-1
- Status last verified
- Jan 2019
- First submitted
- 26 Jul 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only the originating site of study will have the identity log linking the participants to the study records.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining
- ClinicalTrials.gov ID
- NCT03275142
- Acronym / sponsor ID
- 170608-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Comprehensive EyeCare of Central OhioUniversity, hospital or other
- Collaborators
- Icare USA
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 7 Sep 2017 (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.
To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.
Detailed description
Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icare Applanation | Experimental | Device: Icare tonometerEvaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation. |
| No ICare Applanation | Active comparator | Device: Icare tonometerEvaluation of corneal stability post-applanation with Icare tonometer via pre and post applanation keratometry readings with IOL Master, topography with Pentacam, fluorescein corneal staining. Patient's OD and OS are randomized into "study" or control, then undergo applanation with Icare. Investigator is masked as to which eye has undergone applanation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age
Key exclusion criteria (1 listed)
- Under 18 years of age
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 |
|---|---|---|
| Icare tonometerAlso: Icare, applanation, tonometryIcare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale. | Device | Icare Applanation, No ICare Applanation |
Primary outcome
Demonstration of corneal stability post-applanation with the Icare tonometer.
Time frame: 30 minutes
Demonstration that the Icare tonometer does not alter keratometry readings performed by IOL Master, topography performed by Pentacam HR, or corneal staining as evaluated at slit-lamp with fluorescence as compared to the Oxford Grading Scale
3 secondary outcomes
Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.
Time frame: 10 minutes
Total cylinder differences pre and post-tonometry with ICare tonometer.
Time frame: 10 minutes
Difference in corneal staining pre and post-tonometry with ICare Tonometer.
Time frame: 10 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 30 Jan 2019.
- Individual participant dataSharing planned: No. Only the originating site of study will have the identity log linking the participants to the study records.
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.
Kenneth A Beckman, M.D. study director
Comprehensive EyeCare of Central Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icare tonometer in people with Evaluation of Corneal Stability Post-applanation, run by Comprehensive EyeCare of Central Ohio at 1 site in United States.
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 30 Jan 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 United States. 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?
Demonstration of corneal stability post-applanation with the Icare tonometer. (time frame: 30 minutes). 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 30 Jan 2019.