Journal of refractive surgery (Thorofare, N.J. : 1995) · 2018
Retrospective Comparison of Visual Outcomes After KAMRA Corneal Inlay Implantation With Simultaneous PRK or LASIK.
Сравнительное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Moshirfar Majid, Bean Andrew E, Albarracin Julio C, Rebenitsch Ronald L, Wallace Ryan T, Birdsong Orry C
Аннотация
PURPOSE: To report a retrospective study of simultaneous LASIK versus photorefractive keratectomy (PRK) with accompanying small-aperture cornea inlay implantation (KAMRA; AcuFocus, Inc., Irvine, CA) in treating presbyopia.
METHODS: Simultaneous LASIK/inlay and simultaneous PRK/inlay was performed on 79 and 47 patients, respectively. Follow-up examinations were conducted at 1, 3, and 6 months postoperatively. The main outcome measures were safety, efficacy, predictability, and stability with primary emphasis on monocular uncorrected near visual acuity (UNVA).
RESULTS: Both groups met U.S. Food and Drug Administration criteria for efficacy with 95% and 55% of the LASIK/inlay group and 83% and 52% of the PRK/inlay group having a monocular UNVA of 20/40 (J5) and 20/25 (J2), respectively, at 6-month follow-up. Ninety-two percent of the LASIK/inlay group and 95% of the PRK/inlay group had a UDVA of 20/40 or better at 6 months. Two eyes lost one line of corrected distance visual acuity (CDVA). Mild hyperopic shift was noted in both groups at 6 months.
CONCLUSIONS: Simultaneous PRK/inlay and LASIK/inlay meet the U.S. Food and Drug Administration standards for efficacy and safety based on 6-month preliminary results and have similar outcomes to emmetropic eyes. [J Refract Surg. 2018;34(5):310-315.].
METHODS: Simultaneous LASIK/inlay and simultaneous PRK/inlay was performed on 79 and 47 patients, respectively. Follow-up examinations were conducted at 1, 3, and 6 months postoperatively. The main outcome measures were safety, efficacy, predictability, and stability with primary emphasis on monocular uncorrected near visual acuity (UNVA).
RESULTS: Both groups met U.S. Food and Drug Administration criteria for efficacy with 95% and 55% of the LASIK/inlay group and 83% and 52% of the PRK/inlay group having a monocular UNVA of 20/40 (J5) and 20/25 (J2), respectively, at 6-month follow-up. Ninety-two percent of the LASIK/inlay group and 95% of the PRK/inlay group had a UDVA of 20/40 or better at 6 months. Two eyes lost one line of corrected distance visual acuity (CDVA). Mild hyperopic shift was noted in both groups at 6 months.
CONCLUSIONS: Simultaneous PRK/inlay and LASIK/inlay meet the U.S. Food and Drug Administration standards for efficacy and safety based on 6-month preliminary results and have similar outcomes to emmetropic eyes. [J Refract Surg. 2018;34(5):310-315.].