Corneal inlay outcomes positive after more than 10,000 cases

New Orleans-Based on the results of more than 10,000 cases, a corneal inlay (Kamra, AcuFocus) for presbyopia seems to be a good treatment option for emmetropic and ametropic presbyopic patients, as well as for presbyopic patients who underwent a previous LASIK procedure, said Minoru Tomita, MD, PhD.

Patients had substantial gains in uncorrected near visual acuity (UNVA) and the vast majority expressed satisfaction with the outcomes.

Two surgical methods for different patients were performed, according to Dr. Tomita, affiliated with the Shinagawa LASIK Center, Tokyo, Japan, and the Department of Ophthalmology, Wenzhou Medical College, Wenzhou, China.

The first was a LASIK procedure performed simultaneously with inlay implantation post-ablation (combined LASIK Kamra [CLK]) and the second was implantation into the pocket interface after a previous LASIK procedure (planned LASIK Kamra [PLK]).

PLK also could have a second step (PLK2) in which the inlay was implanted into a lamellar pocket at least 1 month after primary LASIK (a traditional thin-flap procedure).

During CLK performed from November 2009 to November 2010, the inlay was implanted in 3,317 patients in the non-dominant eye in which a 200-μm flap was created with a femtosecond laser (femtosecond LDV Z6 [Ziemer] or the iFS [IntraLase]).

An excimer laser ablation (Allegretto [WaveLight] or Amaris [Schwind]) was performed with a target postoperative refraction of –0.75 D.

The corneal inlay was implanted after the refraction was corrected.

Standard LASIK was performed in the dominant eye with a targeted 100-μm flap thickness and targeted postoperative refraction of plano.

PLK was performed from November 2010 to August 2013 in 7,148 presbyopic patients who had undergone a previous LASIK procedure. The inlay was implanted in the non-dominant eye.

A corneal pocket was created with a femtosecond laser (Ziemer LDV Z6 or IntraLase iFS), below the previous LASIK flap interface, and the inlay inserted into the pocket interface.

Dr. Tomita reported that patients who underwent CLK gained 8 lines of uncorrected distance VA (UDVA) and 3 lines of UNVA.

Patients treated with PLK/PLK2 lost 1 line of UDVA and gained 3 lines of UNVA.

In both the CLK and PLK/PLK2 groups, the mean UDVA was 20/20 and the mean UNVA was J2. The mean UDVA and UNVA were stable for 1 year postoperatively.

Patient satisfaction was high-90% in both groups after 6 months.

Only 6% of patients in the CLK group and 8% in the PLK/PLK2 group required reading glasses after 3 months.

“The 1-year results from [more than] 10,000 patients with the Kamra Corneal Inlay implanted indicated that this may be a good treatment option for emmetropic and ametropic presbyopic patients and presbyopic patients who underwent a previous LASIK procedure,” Dr. Tomita concluded.

The inlay is not available for sale in the United States and can be used only investigational purposes in the United States. It is available for use in Japan.

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