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    Scleral implant procedure effective in restoring near vision for presbyopia

    Improvement in near visual acuity increased, maintained over 2-year clinical trial



    A scleral spacing procedure for the treatment of presbyopia restored near vision in presbyopic emmetropic patients without adverse effects.



    Amherst, NY—A procedure using scleral implants (Refocus Scleral Implants, Refocus Group) for the treatment of presbyopia achieved a substantial improvement in near visual acuity 2 years after surgery in a single-center study—with 96% of patients having 20/40 or better monocular vision and all patients achieving 20/40 or better binocular vision.

    “In our experience, the scleral spacing procedure was effective for restoring near visual acuity in presbyopic emmetropic patients without adverse effects both objectively and subjectively,” said Dr. Michael Endl, MD, who is in private practice in Amherst, NY, and principal investigator of this study. “The improvement in vision increased and has been maintained over the course of the 2-year clinical trial.”

    Dr. Endl highlighted a number of procedures that are available for treating presbyopia.

    ·      Corneal approaches include excimer laser (multifocal, monovision), femtosecond laser (intrastromal rings), conductive keratoplasty, and corneal inlays.

    ·      Presbyopic correction using IOLs includes monofocal (monovision), multifocal, and accommodating approaches.

    ·      Scleral surgeries include the scleral implant procedure and scleral laser incisions.

    Single-center experience

    Dr. Endl and Claus Fichte, MD, evaluated the effect of the scleral implants on distance-corrected near visual acuity (DCNVA) after implantation at the center with the longest follow-up in a multicenter, prospective, IDE clinical trial.

    Sixty-three eyes of 33 patients (20 men, 13 women) underwent this procedure at Fichte, Endl and Elmer Eyecare. The average patient age at surgery was 54 years (range, 50 to 60 years). The average manifest refraction spherical equivalent (MRSE) was +0.17 D (range, –0.50 to +0.875 D).

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