Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up.

Abstract

PURPOSE:

To report the 3-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay.

SETTING:

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

DESIGN:

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.

• Authors: Orang Seyeddain, Melchior Hohensinn, Wolfgang Riha, Gerhard Nix, Theresa Rückl, Günther Grabner, Alois K Dexl
• Journal: Journal of cataract and refractive surgery (J Cataract Refract Surg) Vol. 38 Issue 1 Pg. 35-45 (Jan 2012) ISSN: 1873-4502 [Electronic] United States
• PMID: 22018596 (Publication Type: Clinical Trial, Journal Article)
• Copyright: Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Chemical References

• Biocompatible Materials
• Polyvinyls
• polyvinylidene fluoride

Topics

• Biocompatible Materials
• Cell Count
• Cohort Studies
• Contrast Sensitivity (physiology)
• Corneal Stroma (surgery)
• Endothelium, Corneal (pathology)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Patient Satisfaction
• Polyvinyls
• Presbyopia (physiopathology, surgery)
• Prospective Studies
• Prostheses and Implants
• Prosthesis Implantation
• Pupil (physiology)
• Refraction, Ocular (physiology)
• Surgical Flaps
• Treatment Outcome
• Visual Acuity (physiology)
• Visual Fields (physiology)