First Author: B.Soloway UNITED STATES
Co Author(s):
Purpose:
To evaluate the IOP at intervals after SSP and PMMA implants (PresView Scleral Implants, Refocus Group, Dallas, TX) (PSI) as compared to pre-operative, unmedicated IOP in NTP and medication controlled POAG subjects
Setting:
: Setting/Venue: FDA monitored Investigational Device Exemption (IDE) sites in the United States in Beverly Hills, CA; Buffalo, NY; Nashville, TN, New York, NY; and San Antonio, TX and Health Canada monitored sites in Hanilton, ON and Vaughan, ON
Methods:
A retrospective study was performed which compared pre-operative IOP in NTP enrolled in the USA FDA monitored IDE study of SSP with PSI for presbyopia in the United States at up to 18 months post-operatively. This data was then compared to the early prospective results of SSP with PSI in subjects with POAG in the health Canada monitored study currently underway in two sites in Ontario, Canada
Results:
Pre-operative unmedicated mean IOP was 14.3mmHg and 29.0mmHg in the USA normotensive presbyopes and the Canadian POAG subjects respectively. Both groups showed an elevation at one day post-op with the mean IOP of 2.4mmHg(+17%) and 4.1mmHg(+14%) respectively. The normotensive cohort mean IOP decreased to 13.8mmHg(-3%), 12.8mmHg(-10%), 12.3mmHg(14%), and 11.8mmHg(-17%) at 1, 6, 12, and 18 months post-operatively. The POAG cohort resumed medications at one day post-op. By the 2 month post-operative visit, a mean reduction of one medication was found with 33% of the patients totally off medication to maintain IOP < 18mmHg was found
Conclusions:
SSP with PSI reduces IOP in both NTP and POAG patients after 2 months post-operatively. The amount of reduction of IOP is directly correlated to the unmedicated pre-operative IOP. Long term reduction is seen in NTG subjects, however additional measurements are required to determine the continued efficacy in POAG patients.
Financial Disclosure:
... gains financially from product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented
