MAY 25, 2018
In this retrospective study, investigators report vision outcomes in patients who underwent LASIK or photorefractive keratectomy (PRK) with accompanying small-aperture cornea inlay implantation (Kamra, AcuFocus).
The study included presbyopic patients who underwent simultaneous LASIK/Kamra (n=79) or simultaneous PRK/Kamra (n=47). The refractive target was -0.75 D. Patients were evaluated at 1 month, 3 months and 6 months.
At the 6-month follow-up, 95% and 55% of the LASIK/Kamra group and 83% and 52% of the PRK/Kamra group achieved a UNVA of 20/40 and 20/25, respectively. More than 90% of eyes in both groups achieved a UDVA of 20/40 or better.
Approximately 1% of LASIK/Kamra and 2% of PRK/Kamra patients lost 2 lines of CDVA. A mild hyperopic shift was noted in both groups at 6 months.
This study is limited by its retrospective nature and use of unoptimized surgical parameters such deeper stromal pockets that are now commonly used. The Kamra inlay is approved by the FDA to be placed in a virgin cornea, and there have been concerns that performing concurrent excimer ablation with inlay placement may increase keratocyte activation and diminish safety. Although 6 months is likely long enough to determine if there is any increase in risk, a longer follow up period would have been ideal. Finally, only 55% of the cohort completed 6 months of follow-up.
All parameters meet the FDA’s standards for efficacy and safety at 6 months. Given these findings, performing LASIK or PRK with simultaneous Kamra implantation appears safe for patients who are not already at an optimal preoperative refraction. This would increase the number of patients who could qualify for this presbyopia correction.