Intracorneal inlay for the surgical correction of presbyopia.
OBJECTIVE
To evaluate the clinical safety and efficacy of the ACI-7000 intracorneal inlay in increasing the depth of field in emmetropic presbyopic patients.


METHODS
Beyoglu Eye Research and Education Hospital, Istanbul, Turkey.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The ACI-7000 intracorneal inlay showed the potential to provide safe, effective, and reversible treatment of presbyopia.
Yilmaz
Omer F
OF
Beyoglu Eye Research and Education Hospital, Istanbul, Turkey. ofyilmaz@superonline.com
Bayraktar
Sukru
S
Agca
Alper
A
Yilmaz
Basak
B
McDonald
Marguerite B
MB
van de Pol
Corina
C
D001672:Biocompatible Materials; D002244:Carbon; D003319:Corneal Stroma / Q000601:surgery*; D003867:Depth Perception / Q000502:physiology; D005260:Female; D006801:Humans; D007431:Intraoperative Complications; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls; D011183:Postoperative Complications; D011305:Presbyopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019919:Prosthesis Implantation; D013524:Surgical Flaps; D015348:Vision, Binocular / Q000502:physiology; D014792:Visual Acuity / Q000502:physiology; D005465:Fluorocarbon Polymers
D001672:Biocompatible Materials; D002244:Carbon; D008567:Membranes, Artificial; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers