Trial document




drksid header

  DRKS00000581

Trial Description

start of 1:1-Block title

Title

Measurement of intraocular pressure in supine position using a rebound tonometer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Rebound tonometry is used in our clinic since 2008 for measurement of intraocular pressure.
This method is very useful for measurement of intraocular pressure in children, in difficult
situations and for self-tonometry. No application of eyedrops is needed for this method. At this
moment, the first tonometer using rebound tonometry is available at the market for measurement of intraocular pressure in supine position. The intraocular pressure of 100 glaucoma patients will be measured using the iCare PRO tonometer. To test agreement of the new device with standard methods,
intraocular pressure is also measured with the Goldmann applanation, Perkins applanation and the Pascal contour
tonometer. To detect probable confouner test for visual acuity, visual field, corneal pachymetry
are applied.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Since 2008 we use a new device for intraocular pressure measurement called rebound tonometer
(RBT, iCare, Tiolat Oy, Helsinki, Finnland). The method was first described by Kontiola [1].
For the RBT as a new device in many reports a good correlation of measured pressure values
between the RBT and the Goldmann applanation tonometer (gold standard) was shown. Studies
were done for healthy [2], as well as for glaucoma patients [3,4]. moreover, measurement with the
RBT is a safe method, which is also appliable for children. Another study showed a high degree of
intraobserver and interobserver reproducibility [5]. In comparison to the gold standard method
(Goldmann applanations tonometry), the measurement with the RBT shows slightly higher values
[6-8].
Newly, a rebound tonometer is available for measurement of intraocular pressure in supine position. Aim of this
study is to measure intraocular pressure in 100 glaucoma patients using the
new device. The measurement is performed by the doctor.
Additionally, we measure the intraocular pressure using the Goldmann applanation, the Perkins applanation and the Pascal contour tonometer.

References:
1: Kontiola AI. A new electromechanical method for measuring intraocular pressure. Doc
Ophthalmol 1997; 93: 265-76.
2: Garcia-Resua C, Gonzalez-Meijome JM, Gilino J, et al. Accuracy of the new ICare rebound
tonometer vs. other portable tonometers in healthy eyes. Optom Vis Sci 2006; 83: 102-7.
3: Martinez-de-la-Casa JM, Garcia-Feijoo J, Castillo A, et al. Reproducibility and clinical evaluation
of rebound tonometry. Invest Ophthalmol Vis Sci 2005; 46: 4578-80.
4: Sahin A, Niyaz L, Yildirim N. Comparison of the rebound tonometer with the Goldmann
applanation tonometer in glaucoma patients. Clin Exp Ophthalmol 2007; 35: 335-39.
5: Sahin A, Basmak H, Niyaz L, et al. Reproducibility and tolerability of the ICare rebound
tonometer in school children. J Glaucoma 2007; 16: 185-8.
6: Fernandes P, Dias-Rey JA, Queiros A, et al. Comparison of the ICare rebound tonometer with
the Goldmann tonometer in a normal population. Ophthalmic Physiol Opt 2005; 25: 436-40.
7: Martinez-de-la-Casa JM, Garcia-Feijoo J, Vico E, et al. Effect of corneal thickness on dynamic
contour, rebound, and Goldmann tonometry. Ophthalmology 2006; 113: 2156-62.
8: Moreno-Montañes J, Garcia N, Fernandez-Hortelano A, et al. Rebound tonometer

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000581
  •   2010/10/08
  •   [---]*
  •   yes
  •   Approved
  •   10-146, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   H40.1 -  Primary open-angle glaucoma
  •   H40.0 -  Glaucoma suspect
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   No intervention, measurement of intraocular pressure with the rebound tonometer
  •   No intervention, measurement of intraocular pressure with the Goldmann applanation tonometer
  •   No intervention, measurement of intraocular pressure with the Perkins applanation tonometer
  •   No intervention, measurement of intraocular pressure with the Pascal contour tonometer
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

EP:
Measurement of intraocular pressure (mmHg) at a particular time using the rebound tonometer
(iCare PRO). Moreover, measurement of intraocular pressure is performed using the Goldmann
applanation tonometer and the Pascal contour tonometer in seating position and additionally the Perkins applanation tonometer in supine position.
Agreement of the methods is tested by using correlation and Bland-Altman plots.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2010/10/18
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

patients with glaucoma disease, which want to participate in this study

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

patients without glaucoma disease

patients, which do not want to participitate in this study

patients, which are not able to give their agreement for the study

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für Augenheilkunde
    • Mr.  Prof. Dr.  Thomas  Dietlein 
    • Joseph-Stelzmann-Str. 9
    • 50931  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Zentrum für Augenheilkunde Universität zu Köln
    • Mr.  Dr. med.  André  Rosentreter 
    • Joseph-Stelzmann-Str. 9
    • 50931  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zentrum für Augenheilkunde Universität zu Köln
    • Mr.  Dr. med.  André  Rosentreter 
    • Joseph-Stelzmann-Str. 9
    • 50931  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Zentrum für Augenheilkunde
    • Mr.  Prof. Dr.  Thomas  Dietlein 
    • Joseph-Stelzmann-Str. 9
    • 50931  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.