To test the design of a patient care regimen for soft lenses that aims to provide the highest standards of disinfecting through use of domestic microwave cookers, while also providing storage equipment and solution that enable patients to follow a conventional cold disinfecting regimen when traveling. The cleaning efficacy of surfactant agents during microwave treatment was also considered.
The microbiologic performance of the regimen and its disinfecting apparatus was tested according to the Food and Drug Administration (FDA) protocols for contact lens heat disinfectors. Subsequently, a prospective pilot clinical trial of the regimen involving 15 subjects was carried out to the protocols of the FDA and International Standards Organization 11,980:1997.
Lenses inoculated with 107 colony-forming units (cfu) of Enterococcus faecalis were disinfected to 0 cfu by a 12-s irradiation of a compact disinfecting case that held the lenses suspended in 12 ml saline. A proof of operation indicator performed correctly for all 10 cases tested. No adverse reactions were found in the pilot patient trial, using Renu multipurpose (Bausch & Lomb, Rochester, NY) as the test solution, and no statistically significant difference was found between test and control groups in respect of any sign. However, the greater incidence of edema, palpebral hyperemia, and lens front-surface deposition in the microwave test group may be clinically significant.
The design of the test care regimen proved easy for patients to follow in either hot or cold disinfecting mode. The greater incidence of certain signs in the microwave test group suggests the need to continue using a rub and rinse step for the microwave mode and for additional investigation into the choice of an appropriate multipurpose solution formulation for this proposed regimen, preferably one that does not use a block copolymer-type surfactant agent.