Pre-Clinical Trials

Following the development of the IOPtiMate™, extensive pre-clinical studies were conducted in 2007.

 

Clinical Trials

In 2008, the Company conducted clinical trials at three international sites. Thirty patients aged 33 to 84 years successfully underwent the IOPtiMate laser-assisted glaucoma surgery with promising results.  Preliminary analysis of the data shows that average pre-operation IOP was 26.2 mmHg and the average number of medications taken pre-operation was 2.3 per patient. After six months, mean IOP was 14.2 mmHg. In addition, six months after the procedure, 87% of patients had IOP below 21 mmHg without medication (complete success rate) and 93% had IOP below 21 mmHg including cases where post-operation medications were used (qualified success rate). At 12 months post the IOPtiMate procedure the mean IOP 14.3 mmHg which is attributed to an absolute IOP mean reduction of 11.6 mmHg. Complete and Qualified Success Rates at 12 months were 60% and 93.3% respectively with a mean reduction of 2 medications per patient. Mean IOP by test site is displayed below.

 Source: MediStat Summary Statistical Report, October 2009

Future Clinical Trials