Randomized prospective comparison of visian toric implantable collamer lens and conventional photorefractive keratectomy for moderate to high myopic astigmatism. A randomized paired eye comparison of two techniques for treating moderately high myopia: LASIK and artisan phakic lens. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial. Posterior capsule opacification after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM lenses: one-year results of an intraindividual comparison multicenter study. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. 5-Fluorouracil in initial trabeculectomy. A prospective, randomized, multicenter study. Prospective intrapatient comparison of 6.0-millimeter optic single-piece and 3-piece hydrophobic acrylic foldable intraocular lenses. Effect of intraocular lens optic edge design and material on fibrotic capsule opacification and capsulorhexis contraction. A prospective, randomised comparison of single and three piece acrylic foldable intraocular lenses.
To compare the Visian Toric Implantable Collamer Lens (TICL), a toric phakic intraocular lens (IOL), and photorefractive keratectomy (PRK) in the correction of moderate to high myopic astigmatism.
                This prospective, randomized study consisted of 43 eyes implanted with the TICL (20 bilateral cases) and 45 eyes receiving PRK with mitomycin C (22 bilateral cases) with moderate to high myopia (-6.00 to -20.00 diopters [D] sphere) measured at the spectacle plane and 1.00 to 4.00 D of astigmatism. All patient treatment and follow-up occurred at the Naval Medical Center San Diego. Study follow-up was 1 day, 1 week, 1, 3, 6, and 12 months postoperative.
                Mean best spectacle-corrected visual acuity (BSCVA), change in BSCVA, proportion of cases with improvement of 1 or more lines of BSCVA, proportion of cases with BSCVA and uncorrected visual acuity (UCVA) 20/12.5 or better, proportion of cases with BSCVA and UCVA 20/16 or better (6 months, 88% vs 54%, P=.002), and predictability +/-1.00 D (6 months, 100% vs 67%, P<.001) were all significantly better in the TICL group than the PRK group at all time periods studied postoperatively. Similarly, contrast sensitivity, tested at both the 5% photopic level and the 25% mesopic level, was significantly better at all postoperative time points in the TICL group. Mean spherical equivalent refraction was closer to emmetropia (0.28+/-0.41 vs 0.76+/-0.86, P=.005), and predictability +/-0.50 D and stability of manifest refraction (+/-0.50 D and +/-1.00 D) were significantly better in the TICL group at all postoperative visits through 6 months. Mean astigmatism correction at 6 months was not significantly different between the two groups (0.52+/-0.33 vs 0.46+/-0.35, P=.450).
                The TICL performed better than PRK in all measures of safety (BSCVA), efficacy (UCVA), predictability, and stability in this comparison, supporting the TICL as a viable alternative to existing refractive surgical treatments. To compare refractive performance and safety of laser in situ keratomileusis (LASIK) and Artisan phakic intraocular lens (PIOL) for moderately high myopia.
                A prospective, randomized trial with paired eye control.
                Twenty-five patients with myopia ranging from -8.00 to -12.00 diopters (D).
                For each patient, one eye received LASIK and the other one was implanted with an Artisan phakic intraocular lens. The treated eye and the surgical technique were randomized.
                Primary outcome measure was spherical equivalent refraction. Main secondary outcome measures were the change of two or more lines and safety index (ratio postoperative to preoperative best-corrected visual acuity).
                One year after surgery, the mean spherical equivalent refraction was -0.74 +/- 0.67 D for LASIK-treated eyes and -0.95 +/- 0.45 D for Artisan-treated eyes, and the majority of LASIK-treated eyes (64%) and Artisan-treated eyes (60%) were within +/-1.00 D of the intended result. At 1 month, the mean spherical equivalent refraction was -0.28 +/- 0.71 D for LASIK and -1.07 +/- 0.59 D for Artisan (P < 0.01). The changes of two or more lines were in favor of Artisan (P < 0.05). The safety index was significantly better for Artisan (1.12 +/- 0.21) than for LASIK (0.99 +/- 0.17) at 1 year (P < 0.02).
                In cases of moderately high myopia, LASIK and Artisan phakic intraocular lenses seemed to produce a similar predictability. The best-corrected visual acuity and subjective evaluation of quality of vision were better for Artisan. To test the effect of postoperative subconjunctival 5-fluorouracil (5-FU) on the pressure outcome in combined procedure (limbus-based trabeculectomy + clear-cornea phacoemulsification).
                Prospective randomized, controlled clinical trial; n = 24 eyes (24 patients) with concurrent open-angle glaucoma and cataract; 12 eyes per treatment group; sample size adjusted for a minimal expected difference in the event rate between the 2 treatment groups = 50%, control rate = 20%; type I error = 0.05; power = 95%. Uncomplicated limbus-based trabeculectomy + uncomplicated clear-cornea phacoemulsification + posterior chamber intraocular lens. The 5-FU group = five subconjunctival injections of 5 mg 5-FU, starting from day 8 after surgery, one injection per week. Control group = no injections. The groups were matched for age, preoperative intraocular pressure (IOP), duration of preoperative antiglaucoma treatment, preoperative pilocarpine and adrenergics, preoperative laser trabeculoplasty, and beta-blockers in the fellow eye. The IOP less than or equal to 15 mmHg without treatment 1 year after surgery (IOP = average of the two highest values measured in the diurnal curve, 8 AM to 6 PM, one reading every 2 hours).
                Each patient completed a 1-year follow-up. Ten of 12 eyes of the 5-FU group showed an IOP less than or equal to 15 mmHg at the end of follow-up versus 1 of 12 eyes in the control group (Fisher's exact test, P = 0.00064). The IOP range was 10 to 17 mmHg in the 5-FU group and 14 to 22 mmHg in the control group.
                Postoperative 5-FU may improve the 1-year success rate of trabeculectomy combined with clear-cornea phacoemulsification. To perform an intraindividual comparison of posterior capsule opacification (PCO) with 2 foldable intraocular lenses (IOLs) and a foldable acrylic IOL 1 year after in-the-bag implantation.
                Seven German ophthalmology centers.
                In an open prospective randomized multicenter study, each center intraindividually compared a high-refractive-index, sharp-edged optic silicone IOL (CeeOn Edge 911A, Pharmacia) with a high-refractive-index, round-edged optic silicone IOL (PhacoFlex SI-40NB, Allergan) or a sharp-edged optic acrylic IOL (AcrySof MA60BM, Alcon). Of 288 randomized patients, 247 had standard phacoemulsification with in-the-bag IOL implantation in both eyes by the same surgeon. One eye of each patient received a CeeOn Edge IOL and the fellow eye, an AcrySof or PhacoFlex IOL. A morphologic evaluation of PCO was performed using the Evaluation of Posterior Capsule Opacification (EPCO) system 1 to 2 weeks and 11 to 14 months after surgery. The digital pictures were evaluated by an independent investigator who was blind to the type of IOL. Intraindividual differences in EPCO scores were statistically evaluated by a 1-sided binomial test at an alpha-level of 5%.
                One year after surgery, 127 patients with the AcrySof IOL and 102 patients with the PhacoFlex IOL in the control eye were reexamined. Functional results, safety, and handling were not significantly different between the 3 IOLs. All reexamined eyes had a very low PCO grade. The EPCO values revealed less PCO in eyes with the CeeOn Edge IOL than in eyes with the AcrySof or PhacoFlex IOL, but the difference was not statistically significant. A neodymium:YAG laser capsulotomy was performed in 1 eye with a CeeOn Edge IOL, 1 eye with an AcrySof IOL, and 2 eyes with a PhacoFlex IOL.
                The EPCO PCO grade was low 1 year after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM IOLs; there was no statistically significant difference between the IOLs. The impact of IOL material and edge design on PCO development might be relevant in a long-term follow-up of this study. To compare the binocular near vision performance in patients implanted with the 1CU accommodating intraocular lens (IOL) with a multifocal and monofocal IOL.
                Prospective, randomized, double-masked clinical trial.
                Ninety patients presenting for cataract surgery to the Department of Ophthalmology, Hillingdon Hospital were randomized to receive the 1CU accommodative IOL, a multifocal IOL, or a monofocal IOL (control group).
                Patients underwent bilateral sequential phacoemulsification with implantation of 1 of the 3 IOL types and were assessed at 3 and 18 months after second-eye surgery.
                Logarithm of the minimum angle of resolution distance and near visual acuities (VAs) (unaided and distance corrected), contrast sensitivity, and accommodative amplitude (near point and defocusing) were measured at 3 and 18 months. Reading speed was assessed at 18 months, and glare symptoms and spectacle independence were compared using a standardized questionnaire.
                Mean unaided and distance-corrected binocular near VAs were similar in the 1CU and multifocal and were significantly higher than the control group's (P<0.02). There was no significant difference in reading speed between any of the groups, but critical print sizes were similar in the 1CU and multifocal groups and significantly better than the control group's (P = 0.02). The accommodative range was highest in the multifocal group and lowest in the control group, and there was no significant difference between the 1CU and control groups for defocus or near point at 18 months. Of the 1CU group and control group, 71.4% and 63.2%, respectively, experienced no glare at 18 months, compared with only 25% of the multifocal group (P = 0.01). Of the 1CU group and multifocal group, 19% and 27.3%, respectively, were completely spectacle independent at 18 months; none of the control group was (P = 0.05).
                The 1CU accommodating IOL provides improved near vision compared with a monofocal IOL. There is a discrepancy between the near function and accommodative amplitude measured in the 1CU. The multifocal provides excellent near acuity, but photopic phenomena remain a problem inherent in the lens design. Postoperative subconjunctival 5-fluorouracil (5-FU) injections increase the success of filtration surgery in eyes with prior filtration failure or cataract removal and in eyes with secondary glaucoma. The authors evaluate the safety and benefit of adjunctive 5-FU in eyes undergoing initial trabeculectomy.
                Patients with phakic, uncontrolled, open-angle glaucoma who were undergoing initial trabeculectomy were prospectively assigned to the 5-FU group on the first postoperative day. Patients in this group received five 5-mg injections during 2 weeks after surgery. Patients in the control group received no injections.
                Preoperative intraocular pressure (IOP) and number of antiglaucoma medications were similar in the 5-FU (n = 32) and control (n = 30) groups. Transient superficial punctate keratopathy was the only postoperative complication that occurred more frequently (P < 0.05) in the 5-FU (14 eyes) than in the control eyes (3 eyes). Patients were followed for a minimum of 1 year or until a study endpoint was reached: IOP of 21 mmHg or greater with maximum medical therapy (2 5-FU eyes and 8 control eyes; P < 0.03) or cataract removal after filtration (5 treated and 3 control eyes). At last follow-up (mean, > 20 months), IOP and the number of antiglaucoma medications were significantly lower (P < 0.02) in the 5-FU eyes (IOP, 12.0 +/- 1.3 mmHg; medications, 0.2 +/- 0.1) than in the control eyes (IOP, 16.8 +/- 1.3 mmHg; medications, 0.8 +/- 0.2). Intraocular pressure was 20 mmHg or lower in 94% of 5-FU eyes and in 73% of control eyes (P < 0.03) and 16 mmHg or lower in 84% of 5-FU eyes and in 57% of control eyes (P < 0.02).
                Adjunctive 5-fluorouracil increases the rate of success, decreases the level of postoperative IOP, and reduces the need for postoperative antiglaucoma medication in eyes with open-angle glaucoma undergoing initial trabeculectomy. To compare postoperative performance and stability of 6.0-mm optic single- and 3-piece acrylic foldable intraocular lenses (IOLs).
                Prospective, randomized, self-controlled trial.
                Eighty eyes of 40 patients with bilateral senile cataracts.
                Phacoemulsification and IOL implantation were performed. One eye of a patient was randomly assigned to the SA60AT single-piece IOL, and the contralateral eye was allocated to the MA60AC 3-piece IOL.
                Best-corrected visual acuity (BCVA), spherical equivalent, aqueous flare intensity, anterior chamber depth, amount of IOL decentration and tilt, area of anterior capsule opening, and degree of posterior capsule opacification (PCO) were measured 2 days, 1 week, and 1, 3, 6, and 12 months after surgery. Specular microscopy was performed at 12 months postoperatively.
                In the SA60AT group, the anterior chamber depth did not show significant changes after surgery (P>0.05; paired t test), and the refraction remained highly stable throughout the 1-year study period. The MA60AC group showed significant shallowing of the anterior chamber (P<0.05) and a myopic shift (P<0.05) up to 1 month after surgery. There were no significant differences between the 2 groups (P>0.05) in BCVA, aqueous flare intensity, the amount of IOL decentration, IOL tilt, area of anterior capsule opening, and degree of PCO throughout the 12-month follow-up period.
                Both the SA60AT single-piece and MA60AC 3-piece lenses showed a minimum amount of decentration, tilt, anterior capsule contraction, and PCO. Although the MA60AC showed significant forward shift and myopic refractive changes after surgery, the SA60AT displayed little axial movement associated with highly stable refraction after surgery. This feature of the SA60AT should facilitate earlier spectacle prescription and quicker visual/social rehabilitation of patients after cataract surgery. To examine the influence of intraocular lens (IOL) optic edge design and optic material on fibrosis of the anterior and peripheral posterior capsules and on capsulorhexis contraction.
                Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
                This randomized controlled patient- and examiner-masked study comprised 210 eyes of 105 patients with bilateral age-related cataract. In Group 1 (n = 53), the Sensar OptiEdge AR40e hydrophobic acrylic IOL with a sharp posterior optic edge was compared with the AR40 acrylic IOL with a round edge. In Group 2 (n = 52), the ClariFlex OptiEdge silicone IOL with a sharp posterior optic edge was compared with the PhacoFlex SI-40 silicone IOL with a round edge All IOLs were manufactured by Advanced Medical Optics, Inc. Standardized digital slitlamp images of anterior capsule opacification (ACO) and fibrotic posterior capsule opacification (PCO) were taken 1 year postoperatively, and digital retroillumination images were taken at 1 week and 1 year. The intensity of fibrotic PCO was graded subjectively (score 0 to 4), ACO was graded objectively (score 0% to 100%), and the capsulorhexis area (mm(2)) was determined objectively.
                One year after surgery, the mean ACO score was 32% in eyes with the sharp-edged acrylic IOL and 29% in eyes with the round-edged acrylic IOL (P<.05). In the silicone group, the mean was 31% and 26%, respectively (P<.05). The mean fibrotic PCO score was lower in eyes with a sharp-edged acrylic IOL than in eyes with a round-edged acrylic IOL (0.26 and 0.93, respectively; P<.05) and in eyes with a sharp-edged silicone IOL than in eyes with a round-edged silicone IOL (0.24 and 0.82, respectively; P<.001). At 1 year, the mean capsulorhexis area was statistically significantly smaller in eyes with a sharp-edged silicone IOL than in eyes with a round-edged silicone IOL (P<.05).
                Acrylic and silicone IOLs with the sharp OptiEdge design led to significantly less fibrotic PCO but more ACO than round-edged acrylic and silicone IOLs. The sharp-edged silicone IOL caused significantly more capsulorhexis contraction than the round-edged silicone IOL and both acrylic IOLs. To compare the postoperative performance of single and three piece acrylic foldable intraocular lenses (IOLs).
                20 patients underwent bilateral cataract surgery with a single piece SA30AL IOL in one eye and a three piece MA30BA IOL in the other eye. The eyes were randomly assigned to either a single or three piece lens. The amount of IOL decentration and tilt, area of anterior capsule opening, and degree of posterior capsule opacification were measured using the Scheimpflug anterior segment analysis system (Nidek EAS-1000). Visual acuity and contrast sensitivity were examined. Measurements were performed by masked examiners before and 1 day, 1 week, 1, 3, 6, and 18 months after surgery.
                There were no significant differences between the two groups (p>0.05, paired t test) in the amount of IOL decentration, IOL tilt, area of anterior capsule opening, degree of posterior capsule opacification, best corrected visual acuity, and contrast sensitivity throughout the 18 month follow up period.
                The single and three piece acrylic foldable IOLs are equally stable in the eye after surgery.
The results of this review suggest that phakic IOLs are safer than excimer laser surgical correction for moderate to high myopia in the range of -6.0 to -20.0 D and phakic IOLs are preferred by patients. While phakic IOLs might be accepted clinical practice for higher levels of myopia (greater than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism), it may be worth considering phakic IOL treatment over excimer laser correction for more moderate levels of myopia (less than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism). Further RCTs adequately powered for subgroup analysis are necessary to further elucidate the ideal range of myopia for phakic IOLs.