The phakic intraocular lens implant: in-depth focus on posterior chamber phakic IOLs.

Phakic Intraocular surgery has come a long way in the past 20 years, especially in the evolution of posterior chamber phakic intraocular lenses (PC PIOLs). Clinical trials worldwide are showing acceptable results concerning efficacy, predictability, stability, and safety. PC PIOLS are proving to be a promising option for patients with high and extreme ametropia who cannot benefit from conventional corneal refractive procedures. This article provides an in-depth examination of PC PIOLs, their origin and evolution, and the results of past and current clinical studies. Reports of historical importance and studies published since the 1990s in peer-reviewed journals, textbooks, and monthly eye magazines, as well as Food and Drug Administration preliminary clinical findings, are reviewed. Anterior chamber phakic intraocular lenses are mentioned briefly.

Combined posterior chamber phakic intraocular lens and laser in situ keratomileusis: bioptics for extreme myopia.

PURPOSE: To examine the efficacy, predictability, stability, and safety of combined posterior chamber phakic intraocular lens (IOL) implantation and laser in situ keratomileusis (LASIK) in eyes with extreme myopia. METHODS: We analyzed the results of 67 eyes that received a posterior chamber hydrogel-collagen plate phakic IOL (STAAR Collamer Implantable Contact Lens) and also underwent secondary LASIK for the correction of extreme myopia. Mean follow-up was 3 months after the LASIK portion of the procedure (range, 1 day to 6 mo after LASIK). RESULTS: Mean preoperative spherical equivalent refraction was -23.00 +/- 3.60 D (range, -18.75 to -35.00 D), and mean refractive cylinder was 1.50 +/- 1.20 D (range, 0 to 5.00 D). Mean spherical equivalent refraction after IOL implantation and before LASIK was -6.00 +/- 2.80 D (range, -2.00 to -14.38 D) and mean refractive cylinder 1.50 +/- 1.10 D (range, 0 to 5.00 D). Mean postoperative spherical equivalent refraction at last examination after the LASIK portion of the two-part phakic IOL-LASIK procedure was -0.20 +/- 0.90 D (range, +1.75 to -5.13 D), and mean refractive cylinder was 0.50 +/- 0.50 (range, 0 to 2.25 D). Eighty-five percent (57 eyes) were within +/- 1.00 D and 67% (45 eyes) were within +/- 0.50 D of emmetropia at last examination. The refractions remained stable with a statistically insignificant change (P > .05 at each interval) during follow-up. Postoperative uncorrected visual acuity at last examination was 20/20 or better in 3% (2 eyes) and 20/40 or better in 69% (46 eyes). A gain of 2 or more lines of spectacle-corrected visual acuity was seen in 51 eyes (76%) and no eyes lost 2 or more lines of spectacle-corrected visual acuity at last examination. CONCLUSION: Combined posterior chamber phakic IOL implantation with the STAAR Collamer plate lens and LASIK (bioptics) is an effective and reasonably predictable method for correcting myopia from -18 to -35 D. Gains in spectacle-corrected visual acuity were common, and results demonstrated good short-term safety and refractive stability.

Posterior chamber phakic intraocular lens for myopia of -8 to -19 diopters.

PURPOSE: To examine the efficacy, predictability, stability, and safety of posterior chamber phakic intraocular lens (IOL) implantation in patients with extreme myopia. METHODS: We analyzed the results of 124 eyes that received a posterior chamber hydrogel collagen plate phakic IOL (Staar Collamer Implantable Contact Lens, ICL) for the correction of their myopia. The target postoperative spherical equivalent refraction was emmetropia. Mean follow-up was 11 months (range 1 to 36 mo). RESULTS: The mean preoperative spherical equivalent refraction was -13.38 +/- 2.23 D (range, -8.50 to -18.63 D). Mean postoperative spherical equivalent refraction at last examination was -0.78 +/- 0.87 D (range, +1.63 to -3.50 D), with 69% (86 eyes) within +/-1.00 D and 44% (55 eyes) within +/-0.50 D of emmetropia. The refraction remained stable with a statistically insignificant change (p > 0.05 at each interval) during follow-up. A gain of two or more lines of spectacle-corrected visual acuity was seen in 36% (45 eyes) at last examination. One eye (0.8%) lost two or more lines of spectacle-corrected visual acuity from a retinal detachment. CONCLUSION: Posterior chamber phakic IOL implantation with the Staar Collamer plate lens is an effective and safe method for reducing or correcting myopia between -8 and -19 D. Gains in spectacle-corrected visual acuity were common, and results suggested good refractive stability. Improvements in phakic IOL power calculation formulas are needed to improve the predictability of refractive outcome.

Posterior chamber phakic intraocular lens for hyperopia of +4 to +11 diopters.

PURPOSE: To examine the efficacy, predictability, stability, and safety of posterior chamber phakic intraocular lens (IOL) implantation in eyes with high hyperopia. METHODS: We analyzed the results of 24 eyes that received a posterior chamber hydrogel-collagen plate phakic IOL (Staar Collamer Implantable Contact Lens, ICL) for the correction of hyperopia with the goal of emmetropia. Mean follow-up was 8.4 months (range, 1 to 18 mo). RESULTS: The mean preoperative spherical equivalent refraction was +6.51 +/- 2.08 D (range, +3.75 to +10.50 D). Mean postoperative spherical equivalent refraction at last examination was -0.39 +/- 1.29 D (range, +1.25 to -3.88 D), with 79% (19 eyes) within +/-1.00 D and 58% (14 eyes) within +/-0.50 D of emmetropia. Postoperative uncorrected visual acuity at last examination was 20/20 or better in 8% (two eyes) and 20/40 or better in 63% (15 eyes). A gain of two or more lines of spectacle-corrected visual acuity was seen in two eyes (8%) at last examination. One eye (4%) lost two or more lines of spectacle-corrected visual acuity due to progressive neovascular glaucoma initiated by early postoperative pupillary block. CONCLUSION: Posterior chamber phakic IOL implantation with the Staar Collamer plate lens is an effective method for correcting high hyperopia. Large, patent iridotomies are important in hyperopic eyes to lower the risk of postoperative pupillary block. Improved phakic IOL power calculation formulas will refine predictability of refractive outcome.

Results and complications of laser in situ keratomileusis by experienced surgeons.

PURPOSE: To identify intraoperative and early postoperative adverse events and complications that may be encountered after the laser in-situ keratomileusis (LASIK) learning process. METHODS: One hundred sixty-nine consecutive eyes of 108 patients who had LASIK by a surgeon experienced in LASIK were studied. All intraoperative and early postoperative adverse events and complications were noted. Patients were examined at 1 day and 1 to 3 months after surgery. Six baseline refractive groups were studied: high myopia with astigmatism (-10.25 to -17.50 D; 18 eyes), moderate myopia with astigmatism (-6.00 to -9.50 D; 31 eyes), low myopia with astigmatism (-0.75 to -5.87 D; 81 eyes), mixed astigmatism (-0.25 to +0.50 D; 6 eyes), low to moderate hyperopia with astigmatism (+1.00 to +3.75 D; 19 eyes), and high hyperopia with astigmatism (+4.25 to +7.37 D; 12 eyes). Seventy-eight percent (132 eyes) had a primary LASIK procedure; 22% (37 eyes) had LASIK after previous refractive surgery. Primary and secondary LASIK procedures were analyzed together. The Nidek EC-5000 or the Chiron PlanoScan excimer lasers were used. RESULTS: The most commonly observed adverse intraoperative events were minor corneal bleeding (3%) and thin flap (1%). The most commonly observed postoperative events were punctate epithelial keratopathy (6%) and small epithelial defect 1 day after surgery (5%). The most serious complication occurred in three eyes with preoperative high hyperopia (spherical equivalent refraction greater than +4.00 D) in which corneal topographic abnormalities resulted. At last examination, mean postoperative spherical equivalent refraction was less than +1.00 D in all groups. Spectacle-corrected visual acuity was 20/20 in 70 eyes (41%) and 20/25 or better in 119 eyes (70%). Loss of spectacle-corrected visual acuity of two or more lines occurred in five eyes (3%), three of which had preoperative high hyperopia with abnormal postoperative corneal topography. CONCLUSION: Our prospective study should help LASIK surgeons gauge their expectations of intraoperative and early postoperative complications. Surgeons should proceed cautiously when treating patients with high hyperopia, because a higher incidence of loss of spectacle-corrected visual acuity may be encountered postoperatively.

Laser in situ keratomileusis for myopia from -5.50 to -11.50 diopters with astigmatism.

PURPOSE: To determine the efficacy, predictability, safety, and short-term stability of laser in situ keratomileusis (LASIK) in treating patients with high myopia and astigmatism. METHODS: We retrospectively studied the results of our initial 119 eyes with myopia ranging from -5.50 to -11.50 D and astigmatism less than 4.00 D that underwent LASIK with the Nidek EC-5000 excimer laser. Follow-up was at 1 day, 1 month, and 3 to 6 months; follow-up was 71% (84 eyes) at the 3 to 6 month visit (average 4.5 months). RESULTS: Of the 84 eyes with 3 to 6 months of follow-up, mean baseline spherical equivalent refraction was -8.62 +/- 1.27 D and mean cylinder was -1.84 +/- 1.02 D. Mean postoperative spherical equivalent refraction at the last examination was -0.61 +/- 0.84 D and mean cylinder was -0.39 +/- 0.38 D, with 83% (70 eyes) achieving a spherical equivalent refraction within +/-1.00 D of emmetropia, and 56% (47 eyes) within +/-0.50 D. Mean regression of spherical equivalent from 1 day to 1 month was less than -0.50 D and refractions were stable between 1 month and 3 to 6 months. An uncorrected visual acuity of 20/40 or better was noted in 84% (71 eyes) of these eyes on day 1 after surgery, in 75% (63 eyes) at 1 month, and in 77% (65 eyes) at 3 to 6 months. Twenty-two percent (18 eyes) of these eyes achieved 20/20 or better uncorrected visual acuity at 3 to 6 months; only 17% (14 eyes) had 20/20 or better spectacle-corrected visual acuity before surgery. One patient lost two or more lines of spectacle-corrected visual acuity at the last examination due to epidemic keratoconjunctivitis. CONCLUSION: LASIK with the Nidek EC-5000 excimer laser appears to be an effective and safe means for treating patients with high myopia and astigmatism. Studies with longer follow-up will help evaluate the long-term stability of the procedure and the possibility of late complications.

Laser in situ keratomileusis for low myopia and astigmatism with a scanning spot excimer laser.

PURPOSE: To determine the efficacy, predictability, safety, and short term stability of laser in situ keratomileusis (LASIK) in treating patients with low myopia and astigmatism using the Chiron Technolas Keracor 117 PlanoScan excimer laser. METHODS: We retrospectively studied the results of our initial 83 eyes with myopia ranging from -1.13 to -7.25 diopters (D) and astigmatism of no more than 4.00 D that underwent LASIK with the Chiron Technolas Keracor 117 PlanoScan. Follow-up was at 1 day, 1 month, and 3 to 6 months. RESULTS: Mean baseline spherical equivalent refraction was -3.54 +/- 1.41 D and cylinder -1.64 +/- 1.14 D. Mean postoperative spherical equivalent refraction was -0.52 +/- 0.50 D at 1 month and -0.65 +/- 0.62 D at 3 to 6 months; mean postoperative refractive cylinder was -0.45 +/- 0.54 D at 1 month and -0.50 +/- 0.63 D at 3 to 6 months. Fifty-three percent (44 eyes) achieved a spherical equivalent refraction within +/- 0.50 D and 81% (67 eyes) within +/- 1.00 D of emmetropia at the last examination. Fifty-seven percent (47 eyes) achieved a refractive cylinder of < or = 0.50 D, and 27% (22 eyes) had an undercorrection of their refractive cylinder at the last examination. An uncorrected visual acuity of 20/40 or better was achieved in 86% (71 eyes) of patients on postoperative day one, in 81% (67 eyes) at 1 month, and in 76% (63 eyes) at 3 to 6 months. Twenty-eight percent (23 eyes) saw 20/20 or better uncorrected at the last visit (41% [34 eyes] had a baseline spectacle-corrected visual acuity of 20/20). There was no statistically significant difference in the refractions or uncorrected visual acuities between the different postoperative examinations. No eye experienced a loss of spectacle-corrected visual acuity of more than one line at the last examination. CONCLUSION: LASIK with the Chiron PlanoScan excimer laser appears to be an effective, safe, and reasonably predictable means to reduce low myopia and astigmatism. Adjustment of computer algorithms is needed to decrease the number of under-corrections.