GlaucomaNCT01474070
GAT-DCT-Discordance Due to Corneal Properties
An observational study of Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Intraocular Pressure Measurement
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Oct 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: glaucoma patients
Who may be able to join
- clinical diagnosis of glaucoma
Who cannot join
- other optic neuropathy other then glaucoma
- age<18
- corneal surgery
- use of contact lenses
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Ophthalmic Clinic
Zurich, Canton of Zurich, 8091
About this study
Official title: Influence of Discordant Intraocular Eye Pressure Readings Taken by Dynamic Contour Tonometry and Goldmann Applanation Tonometry
IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)).
Read the detailed description
DCT reading will be compared to a corrected GAT reading by the formula of Elsheikh, Alhasso and Pye.
- Trial with medical device
- Conditions
- Glaucoma
- Being tested
- Intraocular Pressure Measurement
- Keywords
- Glaucoma, Goldmann Tonometry, Dynamic Contour Tonometry
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Pressure MeasurementDevice
Also called Goldmann Applanation Tonometry (GAT), Dynamic Contour Tonometry (DCT)
Intraocular pressure is measured with GAT and with DCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
IOP is measured with goldman-applanation tonometer and dynamic-contour-tonometer at the only study visit (V0)
Measured: IOP is measured at the only study visit
Secondary outcomes (1)
Demographical and clinical data
Age, axial length of the eye, central corneal thickness
Measured: study visit V0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2016
- Study completionOct 2016
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 GlaucomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Kniestedt, MD, Principal investigator, University Hospital Zurich, Ophthalmic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474070
- Sponsor's protocol ID
- GAT-DCT-Vergleich
- Status last verified
- Oct 2016
- First submitted
- 3 Nov 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wachtl J, Toteberg-Harms M, Frimmel S, Roos M, Kniestedt C. Correlation Between Dynamic Contour Tonometry, Uncorrected and Corrected Goldmann Applanation Tonometry, and Stage of Glaucoma. JAMA Ophthalmol. 2017 Jun 1;135(6):601-608. doi: 10.1001/jamaophthalmol.2017.1012.
PubMed 28494071
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Discordant Intraocular Eye Pressure Readings Taken by Dynamic Contour Tonometry and Goldmann Applanation Tonometry
- ClinicalTrials.gov ID
- NCT01474070
- Acronym / sponsor ID
- GAT-DCT-Vergleich
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Goldmann Tonometry, Dynamic Contour Tonometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Nov 2011 (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.
IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)).
Detailed description
DCT reading will be compared to a corrected GAT reading by the formula of Elsheikh, Alhasso and Pye.
- Trial with medical device
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients
Key inclusion criteria (1 listed)
- clinical diagnosis of glaucoma
Key exclusion criteria (4 listed)
- other optic neuropathy other then glaucoma
- age<18
- corneal surgery
- use of contact lenses
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 |
|---|---|---|
| Intraocular Pressure MeasurementAlso: Goldmann Applanation Tonometry (GAT), Dynamic Contour Tonometry (DCT)Intraocular pressure is measured with GAT and with DCT | Device | – |
Primary outcome
Intraocular pressure (IOP)
Time frame: IOP is measured at the only study visit
IOP is measured with goldman-applanation tonometer and dynamic-contour-tonometer at the only study visit (V0)
1 secondary outcome
Demographical and clinical data
Time frame: study visit V0
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 18 Oct 2016.
- Derived from this study: PubMed 28494071Wachtl J, Toteberg-Harms M, Frimmel S, Roos M, Kniestedt C. Correlation Between Dynamic Contour Tonometry, Uncorrected and Corrected Goldmann Applanation Tonometry, and Stage of Glaucoma. JAMA Ophthalmol. 2017 Jun 1;135(6):601-608. doi: 10.1001/jamaophthalmol.2017.1012.
- 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.
Christoph Kniestedt, MD principal investigator
University Hospital Zurich, Ophthalmic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Zurich 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 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: finished, as of the sponsor's last update on 18 Oct 2016. 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.
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 (IOP) (time frame: IOP is measured at the only study visit). 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 NCT01474070, 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 18 Oct 2016.