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    Inlay an option for presbyopia at corneal level

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    Outcomes for a cohort of patients with presbyopia with a small-aperture corneal inlay implanted find the device is well tolerated and patient satisfaction is high.

    Implantation of the corneal inlay (Kamra, AcuFocus, Irvine, California, USA) improves near and intermediate vision in presbyopic emmetropes, while having minimal effect on distance vision, and its benefits remain stable during follow-up of 5 years.

    "The small-aperture corneal inlay is an effective and safe treatment for presbyopia, and patient satisfaction with the inlay is high," said Dr Gnther Grabner, at the annual meeting of the American Society of Cataract and Refractive Surgery.

    "The inlay is well-tolerated, but can be removed if desired, and I believe it is an excellent option for treating presbyopia at the corneal level," continued Dr Grabner, professor of ophthalmology and director, Paracelsus Medical University Eye Clinic, Salzburg, Austria.

    He presented outcomes for the first cohort of patients with the small-aperture corneal inlay he implanted beginning in September 2006. The inlay available at that time measured 10 μm in thickness and contained 1600 microperforations to allow nutrient flow. The current generation of the inlay is only 5 μm thick and features 8400 microperforations.

    The series included 32 patients, all of whom had complete follow-up to 4 years, and 17 of whom had reached the 5 year visit. The implantations were done in the nondominant eye under a femtosecond-created flap at an intended depth of 170 μm using topical anaesthesia. Mean age of the patients at time of implantation was 51 years.

    Carefully selected population

    "This was a very carefully selected population for enrolment in the multicentre FDA study, and we screened about 300 patients to identify these 32 individuals who met the strict inclusion criteria," Dr Grabner said.


    Figure 1: Surgical procedure (emmetropes and sim-LASIK).
    Data from follow-up at 4 years for the eye with the inlay showed near uncorrected visual acuity (UCVA) improved from J7/8 at baseline to J2; intermediate UCVA improved from 20/40 preoperatively to 20/25. The patients lost about one line on average for distance UCVA, from 20/16 to 20/20. No eye had distance UCVA worse than 20/32, and binocular distance UCVA stayed unchanged at 20/16. Mean spherical equivalent changed from 0.19 D preoperatively to 0.03 D.

    "For the patients seen at 5 years, the results in the inlay eye remain stable, but we can see some age-related loss in near and intermediate UCVA in the fellow eye," Dr Grabner said.

    He added that near vision function was also evaluated using the Salzburg Reading Desk, and the results showed improvements in reading acuity and speed with a decrease in preferred reading distance.

    "With this test we have objective evidence of improved near vision function," Dr Grabner emphasized.

    Ten patients completed a satisfaction questionnaire at 5 years. When asked if they would have the surgery again, nine responded 'yes' and one said 'maybe'. There were no reports of significant night symptoms. Near vision quality was rated on a scale of 0 (bad) to 7 (very good), and the average score was 5.7.

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