BLOG: LASIK in 2020 – Safer, more precise, better than ever
This overview takes a look at the “state of the union” as it relates to LASIK as we know it in this year of vision, 2020. Here is part two, focusing on FDA approval, current iterations and data.
Clinical trials of LASIK first began in 1991, with FDA approval coming in 1999. While the excimer laser and microkeratome are certainly key in LASIK’s development, femtosecond and wavefront technology are gamechangers that underpin the contemporary gold standard. The femtosecond laser allows for the creation of a more predictable and reproducible flap. The FDA approved IntraLase (Johnson & Johnson Vision) to create a laser-assisted corneal flap in 2001, and wavefront-guided LASIK for custom correction was approved in 2002.
Wavefront technology refines treatment to ablate a more sophisticated aspheric and asymmetric profile based on aberrometry readings. Along with computerized topography, wavefront systems can more predictably correct higher-order or induced aberrations providing a customized result.
Optimized treatment systems are also available, the concept being that an aspheric laser ablation profile maintains the prolate corneal shape and accounts for the induced spherical asphericity from the laser.
Increasingly, surgeons market “bladeless” LASIK to emphasize the all-laser approach using both an excimer and a femtosecond laser to create the corneal flap. Femtosecond flap creation decreases the risk for microkeratome-associated complications, creates more predictable flap thickness, and decreases the risk for corneal abrasions and induced astigmatism. Popular platforms are iDesign (Johnson & Johnson Vision), Femto LDV (Ziemer Ophthalmic Systems), Victus (Bausch + Lomb) and VisuMax (Carl Zeiss Meditec AG). The iDesign Refractive Studio has wavefront-indications for LASIK, PRK and monovision procedures.
In 2016, 7 years after it began, the FDA, the National Eye Institute and the Department of Defense reported on their long-awaited LASIK Quality of Life Collaboration Project (Eydelman, et al). The project was initiated to help better understand patients’ experiences with LASIK surgery via the validation of a questionnaire. The questionnaire collected patients’ reporting of visual symptoms, dry eye symptoms, satisfaction after LASIK, overall satisfaction with vision, daily functioning and well-being.
The Patient-Reported Outcomes With LASIK (PROWL) studies acknowledged the body of clinical evidence confirming LASIK’s safety and effectiveness. The investigators found that with the valid questionnaire, patients could more accurately assess and report their symptoms and satisfaction.
Two small sample populations of LASIK patients were given the survey. PROWL-1 included 262 active-duty Navy personnel, and PROWL-2 involved 312 civilian participants from around the country. In addition to determining the questionnaire’s functionality, the investigators reported:
Both groups reported high satisfaction rates, between 96% and 99%;
A small but significant subset of patients – those without symptoms prior to LASIK – experienced new visual symptoms such as glare, halos or starbursts, or mild, moderate or severe dry eye symptoms 3 months after surgery;
Overall, the prevalence of visual symptoms and dry eye decreased after having LASIK and improved over time; and
Through the questionnaire, very few patients reported their symptoms impacted their daily activities or well-being.
Next time: More data, and what might the future hold?
Eydelman M, et al. JAMA Ophthalmol. 2017;doi:10.1001/jamaophthalmol.2016.4587.