OHIO — Joshua Tidey is happy with his vision, but that wasn’t always the case.

 

What You Need To Know

  • LASIK is one of the most commonly performed elective procedures in the world and the most popular form of surgery for patients looking to correct vision problems like nearsightedness, farsightedness and astigmatism according to the FDA.

  • It isn’t without risk and is not a procedure appropriate for everyone.

  • Recent draft guidance from the FDA is placing an emphasis on better patient education.

“It’s amazing to be able to sit there and read something," he said. "If I fall asleep on the couch, I’m not going to break my glasses."

For most of his life, he wore glasses.

“From the minute I wake up until the minute I went to bed, I’d have to put them on if I wanted to see more than a few feet," he said.

In Jan. 2020, he had LASIK eye surgery at Clear Choice Custom LASIK Eye Center in Brecksville. His wife drove him home after the procedure.

“When I left the parking lot, there’s a stop sign about a mile away and I opened my eyes, and I could see without glasses," he said. "So, I cried a little bit."

Tidey said he did experience dry eyes after surgery, but that went away after a few months.

“With any vision correction, there are inherent risks and benefits, so you have to kind of weigh all of those different risks and benefits," said Dr. William Wiley, medical director of Clear Choice Custom LASIK Eye Center.

Tidey said Wiley and his colleagues answered all questions and addressed any concerns he had before the procedure, but the day of, he was a little nervous something may go wrong.

“I was worried if my vision is going to get corrected," he said. "If I could have any issues that would make my vision get worse and continue to need glasses, that they would stay dry and irritable for an extended period of time that just became a nuisance, but none of those ended up coming to fruition."

Recent draft guidance released by the FDA calls attention to the importance of thorough patient education prior to LASIK eye surgery.

The FDA is asking for better labeling on LASIK devices that explains the risks and has warnings about potential complications.

The draft guidance also talks about the need for a patient decision checklist that explains realistic expectations for vision after surgery and details why everyone is not a good candidate for LASIK.

“Thankfully LASIK is one of the safest procedures known to mankind," Wiley said. "It has less than a 1% chance of having a side effect. But with that said, it is important to have a very thorough exam to make sure the patients are candidates. Things we are looking for is to make sure the patient doesn’t have severe dry eye or any other underlying eye conditions."

Wiley said he has performed LASIK eye surgery for two decades on about 20,000 patients and said the technology has improved greatly over the years.

“The lasers have had increased safety and efficacy so we are more or less decreasing the side effects and increasing that chance of hitting that 20/20 outcome," he said.

According to the FDA, loss of vision, corneal complications, retinal detachment, dry eyes, pain, double vision, drooping eyelid, and visual symptoms, such as seeing glare, halos, or starbursts, are some potential side effects.

There is also a potential risk of psychological harm. Patients may need glasses for close work and the desired vision correction may not last.

LASIK is a two-stage procedure that involves two lasers that create a flap and imprint a prescription into the patient’s cornea. It takes around 15 minutes.

The goal for most patients is to see clearly without glasses or contacts.

“LASIK has been shown to have a 96-98% satisfaction rate based on a recent study released by the FDA," Wiley said.

Wiley said overall most surgeons are seeing eye-to-eye with the FDA.

All agree risks, benefits and alternatives are critical for patients to understand prior to the elective surgery.

But there has been some resistance to changing the informed consent process.

“So, I think surgeons are anxious looking at the current draft guidance and hoping that it's going to be more inclusive of what we see as informed consent," Wiley said. "And I think with anything, the intent is the right place. We're all looking for better education of our patients and that's where we have to have that common goal in mind. And I think surgeons and the FDA need to work together."

Patients like Tidey see the surgery as a life-changing success, but he encourages others to do their own research.

“Being able to see is quite important, so reading up on this procedure or any other procedure is vital," said Tidey.

Spectrum News reached out to the FDA for a statement:

"The FDA is in the process of considering the nearly 700 public comments submitted on the draft guidance. When issued as final, the guidance will provide recommendations about the content and format for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices."

"Once final, the guidance will represent the agency’s current thinking as it relates to patient labeling information for LASIK devices. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. Please note that a final guidance is different than a final rule, as a final rule sets forth legal requirements that are published in the Code of Federal Regulations."