Intraocular PressurePhase 3NCT00555763
Assessment of a New Goldmann Applanation Tonometer
A Phase 3 study testing Tonometry in people with Intraocular Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Tonometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2007to Jul 2008
- Phase
- Phase 3
- 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
- patient willing to participate and signed informed consent
Who cannot join
- patient under 18 y of age
- patient pregnant
- not steady fixation, nystagm
- corneal scars or corneal disease
- astigmatism higher than 2.5 diopters
- corneal surgery in the past
Show all 13Show fewer
- microphthalmos or buphthalmos
- contact lens wear
- dry eye syndrome
- blepharospasm
- active inflammation of conjunctiva, cornea or uvea
- known allergy to topical oxybuprocain for topical anaesthesia
- known allergy to fluorescein solution (used for applanation tonometry)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Eye Hospital Berne
Bern, Canton of Bern, 3010
About this study
The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.
The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.
Read the detailed description
The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.
The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.
Patients at the Department of Ophthalmology, University of Bern, will be included after informed consent. The study has been approved by the local ethical committee. Routine ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements will be taken with the two tonometers in random order. Prior to pressure measurement, central corneal thickness will be measured with a non-contact method (Optical Low Coherence Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).
- Conditions
- Intraocular Pressure
- Being tested
- Tonometry
- Keywords
- Intraocular pressure, Goldmann tonometry, applanation tonometry, Tonometry, Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonometryDevice
Tonometry : measurement of intraocular pressure with an applanation tonometer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: Tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure in mmHG
Measured: single event
Secondary outcomes (1)
safety of measurement
Measured: single event, up to one week post measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Haag-Streit AG
- Investigators
- Milko E Iliev, MD, Principal investigator, University Eye Hospital BerneSebastian Wolf, MD, Study director, University Eye Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555763
- Sponsor's protocol ID
- 1410
- Other IDs
- 162/07
- Status last verified
- Jul 2011
- First submitted
- 8 Nov 2007
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. doi: 10.1016/0002-9394(60)91818-3. No abstract available.
PubMed 14443098GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.
PubMed 13706587GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.
PubMed 13484216
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Goldmann Applanation Tonometer
- ClinicalTrials.gov ID
- NCT00555763
- Acronym / sponsor ID
- 1410
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular pressure, Goldmann tonometry, applanation tonometry, Tonometry, Ocular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Haag-Streit AG
- Study start
- Aug 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Nov 2007 (estimated)
- 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 classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.
The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.
Detailed description
The classic Goldmann applanation tonometer has been further developed. The applanation principle has been retained, while the internal force transmission and the pressure gauging have been optimized, and the display of results digitized.
The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with the new version of the device, and to test the reliability and reproducibility of measurements, as well as its safety.
Patients at the Department of Ophthalmology, University of Bern, will be included after informed consent. The study has been approved by the local ethical committee. Routine ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements will be taken with the two tonometers in random order. Prior to pressure measurement, central corneal thickness will be measured with a non-contact method (Optical Low Coherence Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Tonometry |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient willing to participate and signed informed consent
Key exclusion criteria (13 listed)
- patient under 18 y of age
- patient pregnant
- not steady fixation, nystagm
- corneal scars or corneal disease
- astigmatism higher than 2.5 diopters
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 |
|---|---|---|
| TonometryTonometry : measurement of intraocular pressure with an applanation tonometer | Device | 1 |
Primary outcome
Intraocular Pressure in mmHG
Time frame: single event
1 secondary outcome
safety of measurement
Time frame: single event, up to one week post measurement
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 14 Jul 2011.
- Background: PubMed 14443098SCHMIDT TA. The clinical application of the Goldmann applanation tonometer. Am J Ophthalmol. 1960 May;49:967-78. doi: 10.1016/0002-9394(60)91818-3. No abstract available.
- Background: PubMed 13706587GOLDMANN H, SCHMIDT T. [Further contribution to applanation tonometry]. Ophthalmologica. 1961 Jun;141:441-56. doi: 10.1159/000304099. No abstract available. German.
- Background: PubMed 13484216GOLDMANN H, SCHMIDT T. [Applanation tonometry]. Ophthalmologica. 1957 Oct;134(4):221-42. doi: 10.1159/000303213. No abstract available. German.
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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.
Milko E Iliev, MD principal investigator
University Eye Hospital Berne
Sebastian Wolf, MD study director
University Eye Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tonometry in people with Intraocular Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 13 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 14 Jul 2011. 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraocular Pressure in mmHG (time frame: single event). 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 NCT00555763, which also lists 3 linked publications.
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 14 Jul 2011.