Evaluating outcomes with a small aperture corneal inlay: global data registry results

Session Details

Session Title: Presbyopic Corrections

Session Date/Time: Monday 15/09/2014 | 16:30-18:30

Paper Time: 16:36

Venue: Boulevard F (Level 1)

First Author: : W.Riha AUSTRIA

Co Author(s): :    M. Maus              

Abstract Details

Purpose:

Evaluate the long-term safety, effectiveness, reliability and predictability of visual outcomes in patients implanted with the small aperture corneal inlay using a pocket-based procedure.

Setting:

Results submitted to the KAMRA Data Registry

Methods:

Retrospective analysis of a series of 8905 presbyopes from 31 centers in 8 countries. The KAMRA™ inlay was implanted into a secondary lamellar pocket either in combination with or without refractive correction using a standardized LASIK procedure. The manifest spherical equivalent refraction (MRSE), uncorrected near acuity (UCNVA), uncorrected distance acuity (UCDVA), best-corrected distance acuity (BCDVA) were evaluated pre-operatively (n = 8905), week 1 (n= 8675), month 1 (n= 8155), month 3 (n= 7180), month 6 (n= 6044), and month 12 (n= 3899). Visual acuity is represented in logMAR.

Results:

UCDVA remained essentially unchanged from -0.001 ± 0.33 at pre-op to -0.03 ± 0.15 at week 1 and was maintained out to 12 months. UCNVA improved 3 lines from 0.55 ± 0.28 at pre-op to 0.25 ± 0.21 at week 1 (p<0.0001) and gained an additional line of improvement at month 1 to 0.20 + 0.18. (p<0.0001). Improvements in UCNVA were maintained over the 12-month follow-up. At 12 months, the MRSE in the inlay eye was -0.95D ± 0.71D. Mean BCDVA remained unchanged between pre-op and 12-months post-op with 99.6% of patients achieving a BCDVA of >20/25 at 12 months. 1.62% lost 2 or more lines of BCDVA, however no patient had BCDVA worse than 20/40. 90% of patients were within ±1.0D of intended refraction refractive error at 12 months. The inlay removal rate for this large series was 1.2%.

Conclusions:

Pocket-based procedures provide a significant, 4-line improvement in near vision without compromising uncorrected or best-corrected distance vision. Results are stable over time and the removal rate is low.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented