Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up.
OBJECTIVE
To report the 3-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay.


METHODS
University Eye Clinic, Paracelsus Medical University, Salzburg, Austria.


METHODS
Prospective nonrandomized noncomparative cohort study.


METHODS
The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications were evaluated.


RESULTS
The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 preoperatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night-vision problems and 6.3% (versus 87.5% preoperatively) reported being dependent on reading glasses.


CONCLUSIONS
These 3-year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA.
University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. o.seyeddain@salk.at
Orang
O
Seyeddain
Melchior
M
Hohensinn
Wolfgang
W
Riha
Gerhard
G
Nix
Theresa
T
Rückl
Günther
G
Grabner
Alois K
AK
Dexl
D001672:Biocompatible Materials; D002452:Cell Count; D015331:Cohort Studies; D015350:Contrast Sensitivity / Q000502:physiology; D003319:Corneal Stroma / Q000601:surgery*; D004728:Endothelium, Corneal / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls; D011305:Presbyopia / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D019736:Prostheses and Implants; D019919:Prosthesis Implantation; D011680:Pupil / Q000502:physiology; D012029:Refraction, Ocular / Q000502:physiology; D013524:Surgical Flaps; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014794:Visual Fields / Q000502:physiology; D005465:Fluorocarbon Polymers
D001672:Biocompatible Materials; D011145:Polyvinyls; C024865:polyvinylidene fluoride; D005465:Fluorocarbon Polymers