A new method for Intra Ocular Pressure in vivo measurement: first clinical trials.
Glaucoma is an ocular disease clinically manifested by an abnormal rise of the Intra Ocular Pressure (IOP) that causes lesions of the optic nerve and can lead to blindness. Ophthalmologists currently use applanation tonometers whose utilization induces multiple constraints. We propose an investigative method being at one and the same time atraumatic and ambulatory. This original device, taking profit of a physical relation between frequency of mechanical vibration of the ocular globe and IOP, involves vibrometry by laser interferometry and spectral analysis of a mechanical impulse using a temporal micro hammer. The laser energy delivered to the eye by the device was confirmed to be safe and in full agreement with the authorized security norms. After preliminary in vitro experiments performed using enucleated animal eyes, we made a clinical study on 25 volunteers to evaluate the innocuity and the reliability of this device and to quantify the reproducibility of measurements. All patients declared that discomfort is comparable with that felt during similar tests. Reliability is good and the intra individual reproducibility reveals a high value (R > or = 0.93). These works will be carried on to check the correlation between the variation of measured values (resonance frequency of the eye-ball) and the variation of reference (IOP) values.
Dubois
Patrick
P
INSERM U 703, Institut de Technologie Médicale, CHRU Lille France. pdubois@chru-lille.fr
Zemmouri
Jaouad
J
Rouland
Jean Francois
JF
Elena
Pierre Paul
PP
Lopes
Renaud
R
Puech
Philippe
P
D000328:Adult; D002986:Clinical Trials as Topic; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D007368:Interferometry / Q000295:instrumentation* / Q000379:methods; D007429:Intraocular Pressure / Q000502:physiology*; D007834:Lasers; D008297:Male; D010865:Pilot Projects; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D014065:Tonometry, Ocular / Q000295:instrumentation* / Q000379:methods