Patients demonstrate good results with hyperopic SMILE
Key takeaways:
- Hyperopic SMILE received a CE mark in Europe in 2024.
- At the winter ESCRS meeting, a pioneer of the procedure presented early results in patients treated with hyperopic SMILE post-approval.
ATHENS, Greece — Patients treated with hyperopic SMILE, which received a CE mark in 2024, show promising results, according to a speaker at the ESCRS winter meeting.
“This procedure is a very nice addition to the armamentarium of refractive surgeons for hyperopia, which is always a challenge,” Pavel Stodulka, MD, PhD, told Healio.
Stodulka was one of the lead surgeons in a Zeiss clinical study that explored hyperopic SMILE, and he has continued to treat patients with the procedure at his two clinics in the Czech Republic.
“Patients were waiting a long time for this procedure, and we are so happy that we can offer it to our patients,” he said.
In a presentation, he shared results from 18 eyes of nine patients with a 3-month follow-up. Distance vision was maintained close to 20/20, and near visual acuity improved from J11 to J1 in all patients.
He recommended SMILE for mid to high hyperopia in patients up to the age of 40 years.
“For hyperopic patients of presbyopic age, our first choice is refractive lens exchange with trifocal IOL implantation, but for the younger patients who can still accommodate, hyperopic SMILE is our No. 1 choice,” he told Healio. “The range is from +1 D to +6 D, and you can add up to +5 D of cylinder, ending up with a maximum postoperative keratometry reading of 51 D. If you have a flatter cornea you can correct more diopters, while with a steeper cornea you are a little more limited.”
The end result on the cornea is stable with a high-quality optical zone that is even and symmetric, which contributes to good quality of vision.
“With SMILE, the cornea has a more optimal shape after the procedure compared to LASIK,” Stodulka said.
He said that the docking step of surgery is easy with the Visumax 800 (Carl Zeiss Meditec), and the procedure is short with no real challenges for experienced SMILE surgeons. The results take slightly longer to stabilize as compared with myopic SMILE, and patient adaptation is therefore a little slower. Occasionally some haze is seen in the midperiphery, but it is usually not clinically significant.
The patients treated within the Zeiss study have now reached 5 years of follow-up and are doing well, Stodulka said.
“I would like to emphasize that the current CE mark process in the EU takes way too long ... and this harms development and what we can deliver to our patients,” he said in the presentation.
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Stodulka P. Hyperopic RELEX SMILE. Presented at: ESCRS winter meeting; Feb. 28-March 2; Athens, Greece.