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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
The Kelman Duet phakic intraocular lens: 1-year results.
Journal of Refractive Surgery 2007 November
PURPOSE: To evaluate the efficacy and safety of the Kelman Duet phakic intraocular lens (PIOL) for correction of moderate and high myopia.
METHODS: Kelman Duet PIOLs were implanted in 169 eyes of 110 patients with moderate or high myopia. In all cases, implantation of the lens was feasible through an incision of less than 2.5 mm without complications. Uncorrected visual acuity (UCVA), manifest refraction, best spectacle-corrected visual acuity (BSCVA), intraocular pressure, central corneal endothelial change, and complications were recorded preoperatively and during 12 months of follow-up.
RESULTS: Following PIOL implantation, 23 (13.61%) eyes required LASIK retreatment for the correction of residual astigmatic refractive error and were excluded from the refractive analysis. Best spectacle-corrected visual acuity remained the same or improved in 95.04% of eyes, 81.30% of eyes (100) were within +/-1.00 diopter (D) of emmetropia, and 57.72% (71) were within +/-0.50 D. Intraocular pressure increased slightly in the first 4 weeks postoperatively but stabilized to the preoperative level by 3 months. Mean endothelial cell loss at 12 months was 5.43%. Oval pupils developed in 10.1% of eyes. Haptic exchange or reposition was performed in 7.76% of cases.
CONCLUSIONS: The Kelman Duet PIOL was safe and effective for the correction of moderate to high myopia in this study with 1-year follow-up and offered the advantage of using a 2.5-mm or less incision width. Accurate haptic sizing remains a challenge and haptic exchange to correct haptic size mismatching is possible.
METHODS: Kelman Duet PIOLs were implanted in 169 eyes of 110 patients with moderate or high myopia. In all cases, implantation of the lens was feasible through an incision of less than 2.5 mm without complications. Uncorrected visual acuity (UCVA), manifest refraction, best spectacle-corrected visual acuity (BSCVA), intraocular pressure, central corneal endothelial change, and complications were recorded preoperatively and during 12 months of follow-up.
RESULTS: Following PIOL implantation, 23 (13.61%) eyes required LASIK retreatment for the correction of residual astigmatic refractive error and were excluded from the refractive analysis. Best spectacle-corrected visual acuity remained the same or improved in 95.04% of eyes, 81.30% of eyes (100) were within +/-1.00 diopter (D) of emmetropia, and 57.72% (71) were within +/-0.50 D. Intraocular pressure increased slightly in the first 4 weeks postoperatively but stabilized to the preoperative level by 3 months. Mean endothelial cell loss at 12 months was 5.43%. Oval pupils developed in 10.1% of eyes. Haptic exchange or reposition was performed in 7.76% of cases.
CONCLUSIONS: The Kelman Duet PIOL was safe and effective for the correction of moderate to high myopia in this study with 1-year follow-up and offered the advantage of using a 2.5-mm or less incision width. Accurate haptic sizing remains a challenge and haptic exchange to correct haptic size mismatching is possible.
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