Test report and a comparison of the pressure measurements
of the digital portable tonometer DIATON for the measurement of the intraocular pressure through the eyelid

Ina Conrad-Hegegerer MD., Mr. Fritz Hengerer MD.
Eichenstrasse 3, 65468 Trebur, Germany

The measurements have been conducted in Germany, in our private doctor's office by Mrs. Ina Conrad-Hegegerer MD. and Mr. Fritz Hengerer MD.

The results have been obtained with the following methods:

1. Applanation tonometry by Goldmann(Splitlamp Haag Streit 900)
2. Digital portable Tonometer Diaton
3. Non-Contact tonometry with Niedek Tonometer 1000

The purpose of the measurements is to evaluate the reliability of Diaton in the direct comparison with the already established processes.

There were 2 groups of test persons: Healthy subjects and glaucoma patients. Exclusion criteria were: Previous glaucoma patients, eyelid operations or inflammatory states of the front eye section. Furthermore, patients were excluded where a Goldmann tonometry could not be performed (Keratokonus, Epitheledema).

The static analysis contains:

a) Mean
b) Standard deviation
c) Median error
d) Correlation coefficient (Pearson)

Table 1. shows the measurements on healthy patients, Table 2. on those with glaucoma.

The results of the statistical analysis are summarized in Table 3. and 4.

Summary:
The analysis of the measurements confirms the validity of the measurements of the digital portable Tonometer Diaton.

The researcher is able to perform the measurements of the eye pressure on the sitting, as well as on the lying patient. The procedure is exceptionally suitable for patients with allergies, as anesthesia is not required. Furthermore measurements can be conducted on patients with a Blepharospasm (a lid spasm that occurs when the eyelid is touched) or in cases of cornea trauma, where non-contact-tonometry or applanation tonometry (Goldmann) are mostly impossible.

The clinical everyday life has shown that an easy sterilization of the portable tonometer as well as the low weight is of a great advantage and they also allow IOP-measurements at home visits by the doctor or councils.

Overall the measurements via the eyelid have been found by more then 90% of the tested as more comfortable in direct comparison to the other 2 processes, as well as the short measurement time of <3 seconds.

The researcher has to take great care of the correct device placement behind the ciliary edge of the upper eyelid and has to assure that the measurement is performed while looking down, while performing measurements with the portable digital tonometer.

The measurements are not meaningful if performed incorrectly and they may leave an increased eye pressure condition undetected.

I would like to add that IOP-Measurements with the digital portable tonometer DIATON, in a direct comparison with its predecessor TGDc-01 "PRA" are performed even easier, while having a significantly better usability and self-verification. The DIATON tonometer has proven itself very good as well in the clinical all-day life in our doctors office as at home visits. It allows the examiner to perform in a lot of other fields without being dependent on additional "hardware".

There are further studies being conducted to enable special clinical operation fields in surgery such as Refractive surgery, cataract surgery, vitreoretinal surgery (silicon oils) etc.

Table 1. Healthy patients.

Table 2. Glaucoma patients

Table 3. Glaucoma patients

Table 4. Healthy patients