Clinical outcomes and functional visual performance: comparison of the ReSTOR apodised diffractive intraocular lens to a monofocal control.

AIMS: To compare clinical outcomes of patients bilaterally implanted with SN60D3 intraocular lenses (IOLs) with outcomes of bilateral monofocal controls, and to determine the validity of implanting an apodised diffractive lens in a healthy patient population. METHODS: Six unmasked US investigators prospectively enrolled 72 patients aged

Comparison of visual outcomes, photopic contrast sensitivity, wavefront analysis, and patient satisfaction following cataract extraction and IOL implantation: aspheric vs spherical acrylic lenses.

PURPOSE: To determine vision quality when testing two acrylic intraocular lenses (IOLs), AcrysofIQ and AcrysofSingle-Piece, after routine cataract extraction and IOL implantation.SettingStorm Eye Institute and Magill Research Center for Vision Correction, Medical University of South Carolina, Charleston, SC, USA. METHODS: Prospective, randomized, double-masked study that included 53 eyes of 27 patients who underwent bilateral cataract extraction and IOL implantation. Patients were randomly divided into two groups depending on the type of IOL implanted: AcrysofIQ or AcrysofSingle-Piece. Preoperative, 1- and 3-month postoperative evaluations included ETDRS visual acuity, photopic contrast sensitivity, pupil size, wavefront testing, and a subjective questionnaire. Comparisons between the two groups and comparisons to baseline were made at each visit. P<0.05 was considered statistically significant. RESULTS: Preoperative, statistically significant differences were evident in response to the subjective questionnaire (near activities, driving dimensions, and overall score) between the two groups. Postoperatively there was a greater increase in contrast sensitivity at 1 and 3 months in the AcrysofIQ group when compared to baseline. Patients with AcrysofIQ IOL had a significant reduction in total high-order aberrations (HOA) and spherical aberration (SA) when compared to those patients with AcrysofSingle-Piece at 1 and 3 months and to baseline. Postoperative patient satisfaction showed no difference among the groups. CONCLUSION: The use of a new aspheric acrylic IOL may improve the quality of vision as a result of the reduction of total HOA and SA.

[Diagnosis and treatment of mycobacterial keratitis following LASIK. Case report and review of the literature]. / Diagnose und Therapie der Mykobakteriumkeratitis nach LASIK. Kasuistik und Literaturübersicht.

BACKGROUND: Mycobacterial keratitis is a rare complication following LASIK but can lead to an extremely unfavourable outcome. The diagnosis and treatment is often delayed due to confusion with other entities including diffuse lamellar keratitis and poor clinical outcomes with flap amputation and/or keratoplasty are often the case. PATIENT AND METHODS: We report the results of LASIK in a 51-year-old woman with subsequent early-diagnosed mycobacterial keratitis and compared this case to treatments and outcomes reported in the literature. RESULTS: The patient presented 10 days following LASIK with a white focal infiltrate in the stromal interface. The flap was lifted and cultures from the stromal bed and the reverse of the flap were obtained and the interface irrigated. The patient was treated with topical antibiotics (ciprofloxacin 0.3%, amikacin 2.5%, clarithromycin 40 mg/ml and tobramycin 15 mg/ml) for 8 weeks and at the most recent follow-up she had a visual acuity of 1.25. CONCLUSION: In a large number of published cases in the literature the flap had to be amputated and/or corneal transplants were necessary. Early diagnosis and treatment however, are essential to successfully treat post-LASIK keratitis. Therefore the patients should be followed up carefully in the early postoperative period.

[Diffuse lamellar keratitis: prophylactic treatment with ketorolac tromethamine 0.5% in an animal model]. / Queratitis lamelar difusa: tratamiento profiláctico con ketorolaco trometamina 0,5% en un modelo animal.

PURPOSE: The objective of this study is to evaluate the use of a topical non-steroidal anti-inflammatory drug in the treatment of induced diffuse lamellar keratitis (DLK) in an animal model. MATERIALS AND METHODS: A corneal flap was created in 40 eyes of 20 Dutch-belted rabbits using the ASC microkeratome. The interface was inoculated with either Pseudomonas Aeruginosa Lipopolysaccharide (LPS) endotoxin or Ultra Palmolive liquid dish washer. The rabbits were divided in two groups: Group I (n=20) treated with ketorolac tromethamine ophthalmic solution 0.5% 4 times a day and the group II (n=20) used as control. The rabbits were examined at the slit lamp at day 1, 3, 5 and 7 postoperatively. DLK was graded from I-IV. RESULTS: At the end of the study 31 eyes were available for evaluation. 28 eyes (90%) developed DLK: 86% of the treated group and 94% of the control group during the follow-up. The treated group showed a lower rate of DLK as well as a lower severity. However, no statistically significant difference was found when comparing both groups (P>0.05). CONCLUSION: Pseudomonas aeruginosa LPS endotoxin and Palmolive Ultra can induce DLK in rabbit eyes. The postoperative prophylactic treatment with a topical non-steroidal anti-inflammatory drug showed a tendency towards a lower DLK rate as well as the severity of the disease.

[Diffuse lamellar keratitis. Postoperative prophylactic treatment with corticosteroids in an experimental animal study]. / Diffuse lamelläre Keratitis Tierexperimentelle Studie zur Evaluierung einer postoperativen Kortikosteroidprophylaxe.

PURPOSE: The aim of this experimental ani-mal study was to induce diffuse lamellar keratitis (DLK), and investigate a prophylactic treatment with corticosteroids. MATERIALS AND METHODS: A corneal flap was cut in 40 eyes from 20 Dutch-belted rabbits and the interface inoculated with either Pseudomonas aeruginosa lipopolysaccharide (LPS) endotoxin ( n=21) or Palmolive Ultra soap ( n=19). Half of the eyes were treated with topical corticosteroids and the other half remained untreated. Slitlamp examinations were performed 1, 3, 5 and 7 days postoperatively and DLK was graded from I-IV. RESULTS: At the end of the study 33 eyes were available for evaluation and 94% of the non-treated eyes developed DLK. Out of those eyes treated with steroids 19% developed DLK during the 1 week follow-up period. This was statistically significantly lower ( P=0.018) when compared to the untreated group. CONCLUSION: Pseudomonas aeruginosa LPS endotoxin as well as Palmolive((R)) Ultra caused a very high rate of DLK in rabbit eyes. The postoperative prophylactic treatment with corticosteroids showed a statistically significant lower DLK rate in this rabbit eye model.

Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction. Prospective randomized double-masked study.

PURPOSE: To compare the efficacy of a topical nonsteroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) with that of a topical steroid (rimexolone 1%) to control inflammation after cataract surgery. SETTING: Storm Eye Institute, Department of Ophthalmology, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Thirty-six patients were prospectively and randomly assigned to receive topical treatment with either ketorolac tromethamine 0.5% or rimexolone 1% starting the day after routine cataract extraction. Treatment was masked to both patient and investigator. Each patient had uneventful small incision phacoemulsification with placement of a foldable posterior chamber intraocular lens. Patients used 1 of the 2 antiinflammatory agents 4 times each day starting 24 hours after surgery. No antiinflammatory medications were used preoperatively, intraoperatively, or for 24 hours postoperatively. Signs and symptoms of inflammation, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated 1, 4, 7, and 30 days postoperatively. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements. In addition, there was no difference in IOP measurements between groups. CONCLUSIONS: Ketorolac tromethamine 0.5% was as effective as rimexolone 1% in reducing inflammation after cataract surgery. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery.

PURPOSE: To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. DESIGN: Multicenter clinical study. PARTICIPANTS: One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. METHODS: Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. MAIN OUTCOME MEASURES: The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. RESULTS: Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.

Surgical prevention of posterior capsule opacification. Part 3: Intraocular lens optic barrier effect as a second line of defense.

PURPOSE: To emphasize an important aspect of preventing posterior capsule opacification (PCO), the barrier effect established by the optic of a posterior chamber intraocular lens (PC IOL), and present a new classification regarding capsular bag status after extra-capsular cataract extraction, including phacoemulsification. SETTING: Center for Research on Ocular Therapeutics and Biodevices, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: This analysis included 150 consecutive eyes obtained postmortem with United States-manufactured PC IOLs including (1) poly(methyl methacrylate), (2) silicone, and (3) hydrophobic acrylic designs that were accessioned in the Center from September 1995 to January 1, 1998. Gross photographs from behind (Miyake-Apple views) were taken and serial histologic sections prepared. RESULTS: Microscopic analysis of the 150 eyes showed that the morphologic appearance of the capsular bag could be grouped into 2 categories: (1) those with little or no evidence of retained cortical material and cells, and (2) those with retained cortical material and cells in which a Soemmering's ring formed. With the latter, when a distinct barricade to cellular migration created by the IOL optic was noted, 2 discrete configurations occurred, depending on the different geometries of the optic components. With a classic biconvex optic with a curved and tapered edge, in many instances some ingrowth of cells proceeded posteriorly around the edge of the IOL optic in the direction of the central axis. With a lens optic that had a squared, truncated, and relatively thick edge, there was often abrupt termination of cells at the peripheral edge of the optic. The posterior capsule subtending the entire optic zone was therefore relatively or totally cell free. CONCLUSIONS: The barrier effect of the IOL optic appears to be of critical importance in retarding ingrowth of cells, functioning as a second line of defense when cortical cleanup is incomplete. Analysis of PC IOLs obtained postmortem showed that a square, truncated optic edge seemed to provide the maximum impediment to cell growth behind the IOL optic.

Intraoperative intracameral carbachol in phacoemulsification and posterior chamber lens implantation.

PURPOSE: To evaluate the use of intraoperative intracameral carbachol in association with phacoemulsification and posterior lens implantation. METHODS: We prospectively randomly assigned 41 eyes (41 patients) to receive either placebo or a 50:50 dilution of carbachol 0.01% after intraocular lens insertion and phacoemulsification. RESULTS: Twenty-one eyes of 21 patients treated with intracameral carbachol showed a statistically significant (P = .0373) reduction in intraocular pressure (15.9 mm Hg) at 6 hours postoperatively compared with 20 eyes of 20 patients who had received placebo (20.4 mm Hg). At day 1, the carbachol group measured 15.0 mm Hg vs 17.6 mm Hg for placebo (P = .0376), and a 1.5-line improvement in visual acuity in the carbachol vs the placebo group was noted (P = .0263), which was maintained on glare testing. On quality of life testing using a modified SF-36 test, carbachol-treated patients within the first postoperative week more often attempted to descent stairs in both bright (P = .007) and dim (P = .037) light than did patients treated with placebo. At month 2, no difference was observed between groups except that depth of focus was statistically greater in the carbachol group (P = .025). Safety was similar between the two groups in terms of ocular and systemic adverse events. CONCLUSIONS: Patients treated with carbachol intracamerally after phacoemulsification and posterior chamber lens implantation demonstrate lower intraocular pressure within the first day postoperatively. These findings are associated with improved visual acuity and potentially greater ambulation in bright light within the first postoperative week.

Topical 0.5% ketorolac vs 0.03% flurbiprofen for inhibition of miosis during cataract surgery.

OBJECTIVE: To compare the effects of topical 0.5% ketorolac tromethamine ophthalmic solution (Acular, Allergen Pharmaceuticals, Irvine, Calif) with topical 0.03% flurbiprofen sodium ophthalmic solution (Ocufen, Allergen Pharmaceuticals) on the inhibition of surgically induced miosis during phacoemulsification cataract surgery. DESIGN: One hundred eighteen patients were prospectively randomized to receive 0.5% topical ketorolac or 0.03% topical flurbiprofen at 3 preoperative intervals. The flurbiprofen-treated group served as the control group. The surgeon was masked as to patient selection. Horizontal pupillary diameter measurements were obtained at the start of surgery, just before phacoemulsification, before lens implantation, and after lens implantation. RESULTS: Mean horizontal pupillary diameter measurements for both medications were similar at the start of surgery. However, a consistent trend of larger pupillary diameter was seen in all subsequent surgical intervals in the ketorolac-treated group. Changes from baseline measurements also indicated a more significant inhibition of miosis at all subsequent intervals, and a more stable mydriasis throughout the procedure in the ketorolac-treated group. CONCLUSIONS: Topical ketorolac is an effective inhibitor of miosis during phacoemulsification cataract surgery, and provides a more stable mydriatic effect throughout the surgical procedure.

Effect of surface photorefractive keratectomy and laser in situ keratomileusis on the corneal endothelium.

PURPOSE: To investigate endothelial cell loss in pairs of fresh human autopsy globes following high-diopter myopic photorefractive keratectomy (PRK) or laser in situ keratomileusis (LASIK). SETTING: Center for Research on Ocular Therapeutics and Biodevices and Magill Laser Center for Vision Correction, Storm Eye Institute, Charleston, South Carolina, USA. METHODS: In the first part of the study, 12 globes had either -10 diopters (D) multizone surface PRK or -10 D single-zone LASIK. In the second part, three groups of 5 globes each had -15 D, -20 D, or -25 D multizone-blend LASIK procedures. Fellow globes in both groups were used as untreated controls. Corneoscleral buttons were excised from all globes. Following 7 days in corneal organ culture, the endothelial surface was stained with two vital dyes: calcein-AM and ethidium homodimer. Fluorescence microscopy was used to obtain endothelial cell counts. RESULTS: The mean dead cells per square millimeter (cells/mm2) were 0.94 in the -10 D PRK treated corneas compared with 0.91 in the fellow untreated eyes (P = 0.06(. The mean dead cells/mm2 in the -10 D single-zone LASIK-treated corneas and in the fellow untreated eyes were 0.61 (P = 0.88). The mean dead cells/mm2 in the -15 D, -20 D, and -25 D multizone-blend LASIK-treated corneas were 3.08, 2.33, and 5.55, respectively, compared with 3.49, 1.92, and 5.01 in the fellow untreated eyes (P = 0.276, P = 0.339, and P = 0.427, respectively). Dead cell counts for treated and control paired corneas were highly correlated in all treatment groups. CONCLUSIONS: No significant endothelial cell loss occurred after -10 D PRK or LASIK corrections up to -25 D. Although this study has limitations that prevent direct extrapolation to the clinical situation, it does afford a comparable clinical correlate for endothelial cell toxicity following a typical excimer laser ablations.

A modified preparation technique for closed-system ocular surgery of human eyes obtained postmortem: an improved research and teaching tool.

PURPOSE: In addition to use for corneal transplantation, human autopsy eyes also are used for teaching and vision research. The valuable posterior video technique of Miyake usually is done with an "open-sky" preparation. Closed-system surgery in postmortem eyes is difficult because of postmortem decrease of corneal clarity and myosis. The authors have developed an improved preparation technique that allows closed-system ocular surgery in human postmortem eyes. METHOD: The cornea is dehydrated using a hyper osmolar (15 percent) dextran solution (Swinger-Kornmehl solution), which clarifies the cornea for several hours. The pupil is dilated mechanically by injecting dextran solution into the anterior chamber, and the iris is fixated using formaldehyde (10 percent) and Karnovsky solution. RESULTS AND CONCLUSIONS: This technique can be used in autopsy eyes up to 4 days postmortem without other fixation. Incision techniques, capsulorhexis, phacoemulsification, and intraocular lens implantation, as well as other surgical procedures such as glaucoma surgery, transcleral fixation of posterior chamber lenses and vitrectomies, can be performed. Neodymium:YAG laser capsulectomies or other laser surgical procedures are also possible. This technique is not only excellent for residency training and postgraduate wet laboratories, but is also a viable tool for research purposes.

Cranial injury from unsuspected penetrating orbital trauma: a review of five cases.

Penetrating orbital-cranial injury is potentially life threatening. The history of the trauma and ophthalmologic examination may be misleadingly innocent; serious injury may be overlooked. We present five cases of orbital injury in which the diagnosis of intracranial extension was not obvious at the time of initial examination. A thorough history and physical examination should be performed on all patients, even those with apparently trivial injuries. Intracranial extension should be considered in any case where the injury was caused by an instrument small enough to enter the orbit. The threshold for obtaining a coronal CT scan of the orbits should be lowered, since this is the best way to detect an orbital roof fracture.

A clinical evaluation of two multifocal soft contact lenses.

We fit two multifocal soft contact lenses, Bausch & Lomb's Bi-Tech and the Unilens contact lens from Unilens Corporation, in two separate populations of presbyopes. Most patients (24/42, 57%) had no prior contact lens experience. Patients were evaluated at 6 and 12 months for comfort, visual acuity, lens fit, and corneal findings. Both distance and near vision were found to be slightly decreased with each contact lens when compared to best corrected visual acuity with spectacles. Seventy-seven percent (14/18) of the Unilens wearers and 67% (16/24) of the Bi-Tech wearers continued to wear their lenses for at least 1 year. Those who discontinued lens wear did so because they were dissatisfied with their vision. Presbyopes who seek correction with soft contact lenses appear to be more tolerant of a decrease in distance vision than a decrease in near vision. Both lenses were comfortable and no corneal pathology was induced. Our results suggest that the Unilens (simultaneous vision design) provides more predictable correction of presbyopic symptoms than the Bi-Tech (alternating vision design) because it is independent of lower lid position and translation. Both of these lenses are viable options for the correction of presbyopic symptoms.

Posterior capsule opacification.

A complication of extracapsular cataract extraction with or without posterior chamber intraocular lens (PC-IOL) implantation is posterior capsule opacification. This condition is usually secondary to a proliferation and migration of residual lens epithelial cells. Opacification may be reduced by atraumatic surgery and thorough cortical clean-up. Clinical, pathological and experimental studies have shown that use of hydrodissection, the continuous curvilinear capsulorhexis and specific IOL designs may help reduce the incidence of this complication. Capsular-fixated, one-piece all-polymethylmethacrylate PC-IOLs with a C-shaped loop configuration and a posterior convexity of the optic are effective. Polymethylmethacrylate loops that retain "memory" create a symmetric, radial stretch on the posterior capsule after in-the-bag placement, leading to a more complete contact between the posterior surface of the IOL optic and the taut capsule. This may help form a barrier against central migration of epithelial cells into the visual axis. Various pharmacological and immunological methods are being investigated but conclusive data on these modalities are not yet available.

A comparative evaluation of the biostability of a poly (ether urethane) in the intraocular, intramuscular, and subcutaneous environments.

A transparent poly (ether urethane) (PEU) was considered for use as a foldable intraocular lens material. The PEU was found to possess excellent mechanical, optical, and surface characteristics for this application. In vitro hydrolytic and ultraviolet aging studies suggested the PEU to be tolerant to conditions simulating 3-10 years of normal intraocular exposure. Different behavior was obtained, however, from intraocular and subcutaneous implantation of the PEU. After 6 months of intraocular exposure in the feline model, prototype PEU lenses had lost most or all of their optical resolving power. SEM analysis demonstrated scattered pitting and cracking on the lens surfaces. Degradation was found to be more extreme after as little as 30 days of subcutaneous exposure in rabbits. Severe pitting over the entire surface of implanted flat PEU specimens was observed by SEM. Macroscopic examination showed the samples to be frosty in appearance. It was postulated that the subcutaneous implant environment provides an accelerated in vivo model for materials intended for intraocular use. A minimum acceleration of 6-10x was estimated on a preliminary basis. The PEU studied here was found to be unsuitable for use as a foldable intraocular lens material.

Evaluation of the biocompatibility and fixation of a new silicone intraocular lens in the feline model.

The biocompatibility and fixation of a new silicone intraocular lens was evaluated in the cat eye. Following extracapsular lens extraction, 14 cats were implanted with a silicone lens (SLM 2/UV type) with polypropylene modified J loops in one eye and a poly(methyl methacrylate) (PMMA) lens (Perspex CQ) of a similar design in the fellow eye. Half the lenses were placed in the ciliary sulcus and half in the capsular bag. The eyes were evaluated for up to one year. Neither lens material showed any signs of toxicity clinically or histopathologically. Both lenses achieved stable fixation in the capsular bag; however, some inflammatory reaction and lens dislocation were noted with sulcus placement of both lens types. The amount of proteinaceous and cellular debris on the explanted silicone lenses was significantly less than that on the PMMA lenses as assessed with methylene blue staining. All retrieved lenses were optically clear and no significant change in the lens surface morphology, clarity and/or optical properties was observed.

Protective effect of the anterior lens capsule during extracapsular cataract extraction. Part I. Experimental animal study.

In an experimental study using albino Rex rabbits, the intercapsular cataract extraction (ICCE) technique was performed in 20 eyes with a small anterior capsulotomy. A large, can opener capsulotomy was performed in another 20 eyes, and 10 unoperated eyes served as controls. Endothelial cell loss was determined by vital staining with Trypan blue and Alizarin red S stains. Average endothelial cell loss with the ICCE technique was 1.2%; with the can opener technique, the average cell loss was 6.6%. This difference was statistically significant (P less than 0.01). The percentage of endothelial cell loss in the control eyes was 0.5. A positive correlation between endothelial cell loss related to phacoemulsification time and/or the amount of irrigating fluid used existed for the can opener group only (P less than 0.01). These results demonstrate that the presence of an almost intact anterior lens capsule during removal of lens substance is protective to the corneal endothelium.

Protective effect of the anterior lens capsule during extracapsular cataract extraction. Part II. Preliminary results of clinical study.

In a clinical study, 61 patients underwent phacoemulsification with subsequent intraocular lens (IOL) implantation. An intercapsular capsulotomy with phacoemulsification was performed on 23 patients and a can opener capsulotomy with phacoemulsification on 38 patients. Wide-field specular microscopy was performed preoperatively and postoperatively on all of the eyes in the study. The cell counts were not divulged to the surgeon before or at the time of surgery. Average endothelial cell loss for the intercapsular technique was 3.9%; with the can opener technique, the average cell loss was 10.1%. This difference was statistically significant (P less than 0.01). Positive correlations between endothelial cell loss relating to ultrasound time and/or the hardness of the cataract existed for the can opener group only (P less than 0.01). These results demonstrate that a protective effect is provided by the presence of the anterior lens capsule during lens substance removal.