GlaucomaNCT03684174
Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann
An observational study of Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed statistically significant elevated intraocular pressure measurements compared to the gold standard Goldmann application tonometry. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Intraocular pressure measurement
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 31 Oct 2017
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- Healthy volunteers who agreed to be included in the study and were able to comply with the measurement procedures
- Exclusion criteria were cor-neal abnormalities (such as oedema, scars or dystrophies, astigmatism,hyperopia or myopia > 3 dioptres), a history of ocular surgery or recent(<47 weeks) ocular disorder.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Augenpraxis Centerpassage
Wettingen, Canton of Aargau, 5430
About this study
Official title: Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann Applanation Tonometry: a Device Comparison Study
In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed statistically significant elevated intraocular pressure measurements compared to the gold standard Goldmann application tonometry.
Read the detailed description
Introduction:
Intraocular pressure (IOP) measurement is crucial in glaucoma diagnosis and treatment. We compared a non-contact air tonometer (Topcon CT-1®) with the gold standard Goldmann Applikation tonometer (GAT).
Methods:
In this prospective, mono centric device comparison study, only healthy eyes were enrolled. IOP was measured three times with the Topcon CT-1® followed by three times GAT. Mean IOP was calculated and compared with a paired t-test, a linear regression and a Bland-Altman analysis.
- Conditions
- Glaucoma
- Being tested
- Intraocular pressure measurement
- Keywords
- 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
Pressure tip or air puff is applied on eye
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of GAT with air tonometry Topcon CT1
Difference in mmHg between these two devices
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Apr 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal B Knecht, MD PD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684174
- Sponsor's protocol ID
- 2018-00136
- Other IDs
- 2018
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
PubMed 12049575Jorge J, Gonzalez-Meijome JM, Diaz-Rey JA, Almeida JB, Ribeiro P, Parafita MA. Clinical performance of non-contact tonometry by Reichert AT550 in glaucomatous patients. Ophthalmic Physiol Opt. 2003 Nov;23(6):503-6. doi: 10.1046/j.1475-1313.2003.00139.x.
PubMed 14622352Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.
PubMed 12523884Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Contact Air Tonometry (Topcon CT-1®) Versus Goldmann Applanation Tonometry: a Device Comparison Study
- ClinicalTrials.gov ID
- NCT03684174
- Acronym / sponsor ID
- 2018-00136
- Conditions
- Glaucoma
- Keywords
- Tonometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 25 Sep 2018 (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.
In this prospective device comparison study with 58 healthy eyes, the Topcon CT-1® showed statistically significant elevated intraocular pressure measurements compared to the gold standard Goldmann application tonometry.
Detailed description
Introduction:
Intraocular pressure (IOP) measurement is crucial in glaucoma diagnosis and treatment. We compared a non-contact air tonometer (Topcon CT-1®) with the gold standard Goldmann Applikation tonometer (GAT).
Methods:
In this prospective, mono centric device comparison study, only healthy eyes were enrolled. IOP was measured three times with the Topcon CT-1® followed by three times GAT. Mean IOP was calculated and compared with a paired t-test, a linear regression and a Bland-Altman analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (2 listed)
- Healthy volunteers who agreed to be included in the study and were able to comply with the measurement procedures
- Exclusion criteria were cor-neal abnormalities (such as oedema, scars or dystrophies, astigmatism,hyperopia or myopia > 3 dioptres), a history of ocular surgery or recent(<47 weeks) ocular disorder.
Key exclusion criteria (0 listed)
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 measurementPressure tip or air puff is applied on eye | Device | – |
Primary outcome
Comparison of GAT with air tonometry Topcon CT1
Time frame: 7 months
Difference in mmHg between these two devices
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 25 Sep 2018.
- Background: PubMed 12049575Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.
- Background: PubMed 14622352Jorge J, Gonzalez-Meijome JM, Diaz-Rey JA, Almeida JB, Ribeiro P, Parafita MA. Clinical performance of non-contact tonometry by Reichert AT550 in glaucomatous patients. Ophthalmic Physiol Opt. 2003 Nov;23(6):503-6. doi: 10.1046/j.1475-1313.2003.00139.x.
- Background: PubMed 12523884Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E; Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56. doi: 10.1001/archopht.121.1.48.
- Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
- 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.
Pascal B Knecht, MD PD study chair
University of Zurich
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 2 inclusion and 0 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 25 Sep 2018. 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?
Comparison of GAT with air tonometry Topcon CT1 (time frame: 7 months). 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 NCT03684174, which also lists 4 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 25 Sep 2018.