Yilmaz Omer F, Bayraktar Sukru, Agca Alper, Yilmaz Basak, McDonald Marguerite B, van de Pol Corina
Beyoglu Eye Research and Education Hospital, Istanbul, Turkey.
J Cataract Refract Surg. 2008 Nov;34(11):1921-7. doi: 10.1016/j.jcrs.2008.07.015.
To evaluate the clinical safety and efficacy of the ACI-7000 intracorneal inlay in increasing the depth of field in emmetropic presbyopic patients.
Beyoglu Eye Research and Education Hospital, Istanbul, Turkey.
This prospective unmasked study comprised 39 presbyopic patients; 12 were naturally emmetropic and 27 had emmetropia resulting from previous hyperopic laser in situ keratomileusis. The intracorneal inlay was placed over the pupil in the patient's nondominant eye after flap lift or creation of a conventional flap using a microkeratome. The inlay was centered on the visual axis. Postoperative follow-up was 1 year.
Of the 39 inlays implanted, 3 were explanted during the study. At 1 year, the mean uncorrected near visual acuity improved from J6 (preoperatively) to J1+. All eyes with an inlay had an uncorrected near acuity of J3 or better and 85.3%, of J1 or better. Binocularly, the mean uncorrected near acuity remained J1 or better throughout the study. The mean uncorrected distance visual acuity in eyes with an inlay did not change significantly from preoperatively and remained 20/20 throughout the study period. All 3 eyes with inlay explantation returned to within +/-1.00 diopter of the preoperative refractive state for near and distance vision, with no loss of best corrected distance visual acuity.
The ACI-7000 intracorneal inlay showed the potential to provide safe, effective, and reversible treatment of presbyopia.
评估ACI - 7000角膜内镶嵌物在增加正视老视患者景深方面的临床安全性和有效性。
土耳其伊斯坦布尔贝伊奥卢眼科研究与教育医院。
这项前瞻性非盲研究纳入了39例老视患者；其中12例为自然正视，27例因既往远视性准分子原位角膜磨镶术而获得正视。使用微型角膜刀掀起角膜瓣或制作传统角膜瓣后，将角膜内镶嵌物置于患者非优势眼的瞳孔上方。镶嵌物以视轴为中心。术后随访1年。
在植入的39个镶嵌物中，有3个在研究期间被取出。1年后，平均未矫正近视力从术前的J6提高到J1 +。所有植入镶嵌物的眼睛未矫正近视力达到J3或更好，85.3%达到J1或更好。双眼而言，在整个研究过程中，平均未矫正近视力保持在J1或更好。植入镶嵌物的眼睛平均未矫正远视力与术前相比无显著变化，在整个研究期间保持在20/20。所有3只取出镶嵌物的眼睛在近视力和远视力方面恢复到术前屈光状态的±1.00屈光度范围内，最佳矫正远视力无损失。
ACI - 7000角膜内镶嵌物显示出为老视提供安全、有效且可逆治疗的潜力。
