Journal of cataract and refractive surgery · 2008
Intracorneal inlay for the surgical correction of presbyopia.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Yilmaz Omer F, Bayraktar Sukru, Agca Alper, Yilmaz Basak, McDonald Marguerite B, van de Pol Corina
Аннотация
PURPOSE: To evaluate the clinical safety and efficacy of the ACI-7000 intracorneal inlay in increasing the depth of field in emmetropic presbyopic patients.
SETTING: Beyoglu Eye Research and Education Hospital, Istanbul, Turkey.
METHODS: This prospective unmasked study comprised 39 presbyopic patients; 12 were naturally emmetropic and 27 had emmetropia resulting from previous hyperopic laser in situ keratomileusis. The intracorneal inlay was placed over the pupil in the patient's nondominant eye after flap lift or creation of a conventional flap using a microkeratome. The inlay was centered on the visual axis. Postoperative follow-up was 1 year.
RESULTS: Of the 39 inlays implanted, 3 were explanted during the study. At 1 year, the mean uncorrected near visual acuity improved from J6 (preoperatively) to J1+. All eyes with an inlay had an uncorrected near acuity of J3 or better and 85.3%, of J1 or better. Binocularly, the mean uncorrected near acuity remained J1 or better throughout the study. The mean uncorrected distance visual acuity in eyes with an inlay did not change significantly from preoperatively and remained 20/20 throughout the study period. All 3 eyes with inlay explantation returned to within +/-1.00 diopter of the preoperative refractive state for near and distance vision, with no loss of best corrected distance visual acuity.
CONCLUSION: The ACI-7000 intracorneal inlay showed the potential to provide safe, effective, and reversible treatment of presbyopia.
SETTING: Beyoglu Eye Research and Education Hospital, Istanbul, Turkey.
METHODS: This prospective unmasked study comprised 39 presbyopic patients; 12 were naturally emmetropic and 27 had emmetropia resulting from previous hyperopic laser in situ keratomileusis. The intracorneal inlay was placed over the pupil in the patient's nondominant eye after flap lift or creation of a conventional flap using a microkeratome. The inlay was centered on the visual axis. Postoperative follow-up was 1 year.
RESULTS: Of the 39 inlays implanted, 3 were explanted during the study. At 1 year, the mean uncorrected near visual acuity improved from J6 (preoperatively) to J1+. All eyes with an inlay had an uncorrected near acuity of J3 or better and 85.3%, of J1 or better. Binocularly, the mean uncorrected near acuity remained J1 or better throughout the study. The mean uncorrected distance visual acuity in eyes with an inlay did not change significantly from preoperatively and remained 20/20 throughout the study period. All 3 eyes with inlay explantation returned to within +/-1.00 diopter of the preoperative refractive state for near and distance vision, with no loss of best corrected distance visual acuity.
CONCLUSION: The ACI-7000 intracorneal inlay showed the potential to provide safe, effective, and reversible treatment of presbyopia.
Предметные рубрики MeSH
Biocompatible MaterialsCarbonCorneal StromaDepth PerceptionFemaleHumansIntraoperative ComplicationsMaleMembranes, ArtificialMiddle AgedPatient SatisfactionPolyvinylsPostoperative ComplicationsPresbyopiaProspective StudiesProsthesis ImplantationSurgical FlapsVision, BinocularVisual AcuityFluorocarbon Polymers