PURPOSE: To evaluate the efficacy, safety, and biocompatibility of a collagen polymer implantable contact lens (ICL) (Staar Collamer) as a posterior chamber phakic intraocular lens (IOL) to correct high myopia. SETTING: Departments of Ophthalmology, Helsinki University Central Hospital, Helsinki, and Tampere University Hospital, Tampere, Finland. METHODS: A Staar Collamer posterior chamber phakic IOL was implanted in 38 eyes of 22 patients with a mean age of 39 years (range 24 to 54 years). The mean preoperative myopia was -15.10 diopters (D) (range -7.75 to -29.00 D). Surgical implantation was performed through a 3.0 mm clear corneal sutureless incision using paraocular anesthesia. The patients were followed clinically up to 3 years. The mean follow-up was 13.6 months (range 6 to 24 months) for refractive data and 22.3 months (range 6 to 35 months) for complications. The possible inflammatory response to the ICL was measured using a laser flare meter in 12 eyes. RESULTS: Postoperatively, all eyes had a significant increase in uncorrected visual acuity, allowing all but 3 patients (5 eyes) to manage most activities without spectacles. The mean spherical equivalent refraction at the last examination was -2.00 D +/- 2.48 (SD) (range +0.13 to -13.00 D), within +/-1.00 D of the targeted refraction in 31 eyes (81.6%) and within +/-0.50 D in 27 eyes (71.1%). In eyes in which the preoperative myopia was less than -18.00 D (n = 28), the achieved refraction was within +/-1.00 D of the intended refraction in 27 eyes (96.4%) and within +/-0.50 D in 24 eyes (85.7%). The refraction remained stable with a statistically insignificant change (P >.05) at each interval during the follow-up. The best corrected visual acuity (BCVA) improved by 1 or more lines in 23 of 32 eyes (71.9%) at 1 year. Two eyes (6.3%) lost 1 line of BCVA. Laser flare photometry showed normal aqueous flare values (11.71 +/- 6.61 photon counts/ms) in the 12 eyes measured at least 6 months after ICL implantation. Pupillary block glaucoma requiring surgical intervention occurred in 3 patients (7.9%). One patient (2.6%) developed cataract 1.5 years after ICL implantation; both ICLs were removed, and the refractive errors were corrected by lensectomy and implantation of low-power posterior chamber IOLs. One patient (2.6%) showed progression of dry macular degeneration at 17 months. CONCLUSION: At 1 year, ICL implantation had good visual and refractive results with excellent biocompatibility. Long-term follow-up is required to confirm that significant complications do not occur in most patients over time.
PURPOSE: To evaluate the efficacy, safety, and biocompatibility of a collagen polymer implantable contact lens (ICL) (Staar Collamer) as a posterior chamber phakic intraocular lens (IOL) to correct high myopia. SETTING: Departments of Ophthalmology, Helsinki University Central Hospital, Helsinki, and Tampere University Hospital, Tampere, Finland. METHODS: A Staar Collamer posterior chamber phakic IOL was implanted in 38 eyes of 22 patients with a mean age of 39 years (range 24 to 54 years). The mean preoperative myopia was -15.10 diopters (D) (range -7.75 to -29.00 D). Surgical implantation was performed through a 3.0 mm clear corneal sutureless incision using paraocular anesthesia. The patients were followed clinically up to 3 years. The mean follow-up was 13.6 months (range 6 to 24 months) for refractive data and 22.3 months (range 6 to 35 months) for complications. The possible inflammatory response to the ICL was measured using a laser flare meter in 12 eyes. RESULTS: Postoperatively, all eyes had a significant increase in uncorrected visual acuity, allowing all but 3 patients (5 eyes) to manage most activities without spectacles. The mean spherical equivalent refraction at the last examination was -2.00 D +/- 2.48 (SD) (range +0.13 to -13.00 D), within +/-1.00 D of the targeted refraction in 31 eyes (81.6%) and within +/-0.50 D in 27 eyes (71.1%). In eyes in which the preoperative myopia was less than -18.00 D (n = 28), the achieved refraction was within +/-1.00 D of the intended refraction in 27 eyes (96.4%) and within +/-0.50 D in 24 eyes (85.7%). The refraction remained stable with a statistically insignificant change (P >.05) at each interval during the follow-up. The best corrected visual acuity (BCVA) improved by 1 or more lines in 23 of 32 eyes (71.9%) at 1 year. Two eyes (6.3%) lost 1 line of BCVA. Laser flare photometry showed normal aqueous flare values (11.71 +/- 6.61 photon counts/ms) in the 12 eyes measured at least 6 months after ICL implantation. Pupillary block glaucoma requiring surgical intervention occurred in 3 patients (7.9%). One patient (2.6%) developed cataract 1.5 years after ICL implantation; both ICLs were removed, and the refractive errors were corrected by lensectomy and implantation of low-power posterior chamber IOLs. One patient (2.6%) showed progression of dry macular degeneration at 17 months. CONCLUSION: At 1 year, ICL implantation had good visual and refractive results with excellent biocompatibility. Long-term follow-up is required to confirm that significant complications do not occur in most patients over time.
Authors: José F Alfonso; Carlos Lisa; A Abdelhamid; Paulo Fernandes; Jorge Jorge; Robert Montés-Micó Journal: Graefes Arch Clin Exp Ophthalmol Date: 2010-03-24 Impact factor: 3.117