Laser-Assisted In Situ Keratomileusis (LASIK) is a widely performed refractive surgery that corrects common vision problems like nearsightedness, farsightedness, and astigmatism. The procedure uses a specialized laser to precisely reshape the cornea, the clear front part of the eye, to change its focusing power. For any medical device or surgical procedure to be legally performed in the United States, the Food and Drug Administration (FDA) must grant approval. This regulatory oversight confirms that the technology has undergone rigorous clinical trials to demonstrate that its benefits outweigh the potential risks.
Early Global Development of Refractive Surgery
The conceptual foundation for modern laser vision correction began long before the excimer laser was applied to the human eye. In the 1960s, Spanish ophthalmologist José Ignacio Barraquer developed a technique called keratomileusis in Bogotá, Colombia. This involved mechanically removing, reshaping, and reattaching a layer of the cornea to correct refractive errors. This procedure proved that surgically altering the cornea could successfully change the eye’s refractive power, laying the groundwork for all subsequent surgeries.
A technological leap occurred in the early 1980s with the discovery that the excimer laser could precisely remove organic tissue without causing thermal damage to the surrounding cells. Researchers recognized that this ultraviolet laser, initially used in microchip manufacturing, was suited for corneal reshaping. This led to the development of Photorefractive Keratectomy (PRK), a precursor to LASIK, where the laser was applied directly to the surface of the cornea. The first PRK procedure on a sighted human eye was performed outside the United States in 1988, demonstrating the procedure’s potential.
The Initial US Regulatory Milestone
The US regulatory journey for laser vision correction began with PRK, which received the first FDA approval for an excimer laser in 1995 for the correction of myopia (nearsightedness). This approval was granted to Summit Technology’s excimer laser. LASIK, which combines the excimer laser with the creation of a corneal flap, was already being performed in other parts of the world, having been first performed in Greece in 1990.
The pivotal moment for LASIK in the United States arrived in 1998, when the FDA approved the use of an excimer laser specifically for the LASIK procedure to correct myopia. The first company to receive Pre-Market Approval (PMA) for a LASIK excimer laser was VISX, Inc., with their STAR Excimer Laser System. This initial PMA was limited to correcting specific ranges of nearsightedness, typically up to -7 diopters, and often included limited astigmatism correction. The PMA process required years of extensive clinical trials to demonstrate the safety and efficacy of the laser platform and the surgical technique.
How FDA Approval Evolved with Technology
Following the foundational approval, the FDA continued to review and approve subsequent technological advancements, recognizing that new techniques required separate validation. A significant step was the approval of wavefront-guided LASIK, often referred to as “Custom LASIK,” in the early 2000s. This technology uses a device called an aberrometer to create a detailed map of the eye’s unique optical imperfections. This map guides the excimer laser to deliver a more personalized correction than standard LASIK.
Another evolution was the introduction of the femtosecond laser for flap creation, which received FDA clearance in the early 2000s. This innovation led to “all-laser LASIK,” replacing the mechanical microkeratome blade with a precisely controlled laser to create the corneal flap. Each advancement, whether it was wavefront technology or the femtosecond laser, required the FDA to review new clinical data to confirm the safety and effectiveness of the updated procedure. The FDA’s ongoing oversight ensures that as the technology continues to refine, each new major iteration meets the same standards for quality and patient outcomes.