Simultaneous Intracorneal Inlay Implantation and LASIK for the Treatment of Presbyopia: Six Month Results

1. Minoru Tomita, MD, PhD
2. Satoshi Yukawa, MD
3. Keigo Sekiya, MD, PhD
4. Takahiro Yamamoto, MD
5. Tadahiko Tsuru, MD, PhD

Shinagawa LASIK Center, Tokyo, Japan

Purpose:
To evaluate the safety and efficacy of implanting the Kamra (AcuFocus) intracorneal inlay with simultaneous LASIK surgery for the treatment of presbyopia in emmetropoic, hyperopic, and myopic patients.

Methods:
In this prospective study, 612 consecutive eyes of 612 presbyopic patients with a mean spherical equivalent of -2.6 ± 2.6D (mean ± SD, range: -8.8 to +2.9D) and mean age of 52.6 ± 5.0 years (range: 41 to 65 years) were evaluated. The procedures took place from September 2009 to September 2010. Femtosecond lasers were used for flap creation and excimer lasers were used to correct refractive errors with a targeted post-op refraction of -0.75 D. Kamra intracorneal inlays were implanted immediately after LASIK in the patient's non-dominant eye. The Kamra inlay was centered on the first Purkinje image.

Results:
At six months post surgery, the mean uncorrected distance visual acuity (UDVA) improved 8 lines from 20/125 preoperatively to 20/20 while the mean uncorrected near visual acuity (UNVA) at 30cm improved 4 lines from J9 preoperatively to J2. There were statistically significant differences between preoperative and 6 months postoperative in UNVA (P=0.0001) and UDVA (P<0.0001). Only 8% of the patients need reading glasses at 6 months with high satisfaction rate.

Conclusions:
The six months results of this prospective study demonstrated that simultaneous Kamra intracorneal inlay implantation and LASIK is a safe and effective treatment option for presbiopia in emmetropic, hyperopic, and myopic patients. Patient satisfaction was high and the procedure reduced the patients' dependency on glasses.