Clinical and Laboratory Trials

Tonometry Study Summary
In a clinical trial comparing of the Falck Medical Multifunction Device (FAT1) in 205 eyes the following results were obtained:

• No statistical relationship found between FAT1 readings and corneal curvature or thickness, r2 < 0.05.

Manometric Study Summary
In a comparative study of the FAT1 readings to a reference u-tube mercury manometer using human eye bank eyes, the following results were obtained:

• Average Coefficient of Variation: 2.6% +/- 0.10 (5 to 50mmHg)
• Average Standard Deviation: 0.7 mmHg +/- 0.4 (5 to 50mmHg)

Clinical Tonography Trial Summary
In a clinical trial comparing the FAT1 to a reference indentation tonographer for the measurement of conventional outflow facility in 91 eyes from 91 subjects the following results were obtained:

• The mean conventional outflow facility (C) difference between the FAT1 and the reference Indentation Tonographer over a range of 0.01 to 0.70 ul/min/mmHg was 0.0043 ul/min/mmHg ( 95% CI, 0.001 to 0.0076 ), n= 182
• Average FAT1 conventional outflow facility measurement in the glaucoma group was 0.09 +/- 0.05 and in the non-glaucoma group was 0.31 +/- 0.12 ul/min/mmHg, p < 0.0001, n = 182 Average FAT1 IOP measurement in the glaucoma group was 20.02 +/- 5.5 and in the non-glaucoma group was 18.6 +/- 2.4, p = 0.01, n = 182 In the High outflow facility group (C > 0.18) (non-glaucoma, 28/30 eyes) 93.3% of the paired differences were within +/- 1.96 standard deviations of the mean difference between the FAT1 and the reference Indentation Tonographer, n=60
• In the Medium outflow facility group (C >0.09 < 0.18) (glaucoma, 29/31 eyes) 95.2% of the paired differences were within +/- 1.96 standard deviations of the mean difference, n=62
• In the Low outflow facility group (C < 0.09) (glaucoma, 30/30 eyes) 96.7% of the paired differences were within +/- 1.96 standard deviations of the mean difference, n=60

Tonographic Laboratory Study Summary
In a comparative tonographic laboratory study using freshly enucleated preserved eye bank eyes, the following results were obtained:

• For every 10 mmHg change in IOP average anterior chamber fluid volume change was 3.22 ul/minute, for a 20 mmHg change in IOP average anterior fluid volume change was 7.027 ul/minute and for 30 mmHg change in IOP average anterior fluid volume change was 11.75 ul/minute, r2 = 0.99
• The correlation coefficient for volume decrease and corneal indentation was 0.999
• The correlation coefficient for volume decrease and applanation diameter was 0.997

Clinical Ophthalmodynamometry (OPH) Study Summary
In a clinical trial involving 42 adult eyes where ipsi-lateral OPH force, brachial artery blood pressure and IOP were recorded, the following results were obtained:

• The average OPH estimated Central Retinal Artery Force was 59.73 +/- 11.10 mmHg
• The Mean Brachial Artery Blood Pressure (MBAP) was 93.16 +/- 8.32 mmHg
• The average IOP was 15.72 +/- 3.04 mmHg
• The average calculated Ocular Perfusion Pressure was 44.01 mmHg

*Results on file with the Food and Drug Administration