Since the introduction of LASIK surgery, the debate about how to improve outcomes and increase safety has raged. The consistency of flap thickness made possible by the newer femtosecond lasers has been much praised, but does this in actual fact have the desired effect of reducing the number of intraoperative complications, making the LASIK procedure safer than is possible with a traditional mechanical microkeratome?

Using the study to implement best practice

I conducted a retrospective study comparing the incidence rates and nature of flap complications occurring in a large multi-surgeon, multi-clinic nationwide refractive surgery group between April 2007 and April 2008. Simultaneously, the project acted as an evaluation of a comprehensive synergistic protocol, which was instituted as part of the clinical governance policy of the clinic group. For my comparison I examined a total of 25,885 consecutive LASIK treatments, carried out by 15 surgeons in 19 clinics. Of the treatments in the study, 23,011 (88.9%) involved LASIK flap creation with the AMO IntraLase FS30 femtosecond laser, and 2,874 (11.1%) involved flap creation using either the Hansatome (Bausch & Lomb) or the Moria M2 microkeratome.

For the purposes of the study, the term "flap complication" was defined as an event that either caused, or was likely to have caused, a suspension of the LASIK treatment process. This article reports only on the intraprocedural complications; periprocedural phenomena such as diffuse lamellar keratitis (DLK), epithelial ingrowth and postoperative infection were classified and studied separately.

Standardization: no easy task

Because of the multidisciplinary nature of the project, and its wide-ranging basis, considerable effort was made to ensure standardization of classification and reporting. Such an undertaking requires a great deal of commitment on behalf of surgeons, nursing colleagues and technicians to obtain a meaningful result.

Before the new regime of classification started, it was important not only to cement this standardization process at all centres from the point of view of ensuring consistency of application, but also to define the culture ethos that was deemed central to the project. The company approach to clinical governance policy espouses a no-blame investigation to ensure that, as far as possible, all incidents are reported and classified properly. It is only after such a culture had been instigated and had won the buy-in of all teams concerned that the project was deemed to have commenced. Therefore, although training began in late 2006 and the new recording system was instigated in January 2007, the project itself did not begin to gather results until April 2007. The three-month lead time was to obtain the confidence of all colleagues involved, to ensure that the system was workable and robust, and to ensure that any bugs in the reporting and management system were identified and subsequently addressed.

Complications classification

Figure 1

Prior to the commencement of the project, nine groupings were established to cover the entire range of possible flap complications. Microkeratome complications were classified as free cap, buttonhole, incomplete flap, abrasion and other inability to complete treatment. Instances were further sub-classified depending on the actual instrument used. The femtosecond laser complications were classified as vertical gas breakthrough, inability to achieve suction, inability to maintain suction, or other inability to complete treatment. Each surgeon was given a quarterly graphic summary of the complications for benchmarking purposes, allowing the surgeon to see their own complication rates against those of their (anonymous) peer group. This formed part of each surgeon's quarterly outcomes analysis (Figure 1). Lessons learned from these studies are then disseminated across the group and changes in protocol are implemented accordingly.

Quality assurance in the study came from supervisory input via regional and clinic senior nursing colleagues, with central management co-ordination, ensuring uniform application of policy throughout the study. Therefore, with the culture firmly in place and the progress of the study monitored carefully and frequently centrally, there was considerable evidence that the results would be meaningful.