Saturday, March 24, 2012

Abstract: Simultaneous LASIK and corneal inlay implants

No matter what the scientifically accepted follow-up percentage standards for this sort of cohort study, I am always suspicious of any 6-month complications data that reports results for fewer than half of the patients that underwent ANY elective refractive surgery. Why? Because I know how many people ditch their doctor in favor of someone else when they have post-operative complaints after such a surgery (in contrast to medically necessary eye surgery). 64 out of 180. Really? That the best you could do?

With that in mind you'll understand why I feel I think the word "occasionally" (my highlight below) should be read with sincere skepticism.

Simultaneous corneal inlay implantation and laser in situ keratomileusis for presbyopia in patients with hyperopia, myopia, or emmetropia: Six-month results.

PURPOSE:
To evaluate the safety and efficacy of simultaneous Kamra corneal inlay implantation and laser in situ keratomileusis (LASIK) for the treatment of presbyopia in emmetropic, hyperopic, or myopic patients.

SETTING:
Private center, Tokyo, Japan.

DESIGN:
Cohort study.

METHODS:
Patients had bilateral LASIK with simultaneous implantation of a corneal inlay in the nondominant eye to treat presbyopia and ametropia between September 2009 and April 2010. The efficacy and safety were determined by the spherical equivalent (SE) in the eye with the inlay.

RESULTS:
The study enrolled 360 eyes of 180 patients with a mean age of 52.4 years ± 5.1 (SD) (range 41 to 65 years). Sixty-four patients were available for the 6-month postoperative examination. The mean logMAR uncorrected near visual acuity in the eye with the inlay improved 7 lines in hyperopic eyes, 6 lines in emmetropic eyes, and 2 lines in myopic eyes. The mean logMAR uncorrected distance visual acuity improved by 3 lines, 1 line, and 10 lines, respectively.

CONCLUSIONS:
Simultaneous intracorneal inlay implantation and LASIK to treat presbyopia with emmetropia, hyperopia, or myopia was clinically safe and effective, yielding improvement in distance and near visual acuity. Patients were satisfied with decreased dependence on reading glasses regardless of the preoperative SE range. However, postoperative symptoms, such as dry eyes, halo, glare, or night-vision disturbances, occurred occasionally.

FINANCIAL DISCLOSURE:
Dr. Waring has a financial interest in and is world surgical monitor for Acufocus. No other author has a financial or proprietary interest in any material or method mentioned.


J Cataract Refract Surg. 2012 Mar;38(3):495-506.
Tomita M, Kanamori T, Waring GO 4th, Yukawa S, Yamamoto T, Sekiya K, Tsuru T.
Source
From the Shinagawa LASIK Center (Tomita, Kanamori, Yukawa, Yamamoto, Sekiya, Tsuru), Tokyo, Japan; ReVision Advanced Laser Eye Center (Waring), Columbus, Ohio, and St. Joseph's Translational Research Center (Waring), Atlanta, Georgia, USA.

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