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.

Contrast sensitivity evaluation after laser in situ keratomileusis.

OBJECTIVE: To determine the effects of laser in situ keratomileusis (LASIK) on best-corrected visual acuity (BCVA) and contrast sensitivity. DESIGN: Prospective, observational case series. PARTICIPANTS: One hundred twelve eyes, in 65 patients with myopia and myopia with astigmatism, who underwent LASIK. TESTING AND MAIN OUTCOME MEASURES: Best-corrected visual acuity using the Snellen visual acuity chart and contrast sensitivity using the CSV 1000 (Vector Vision, Dayton OH) was tested before surgery and 1 week, 1 month, and 3 months after surgery in patients who underwent LASIK. RESULTS: Contrast sensitivity was depressed for patient eyes with spherical equivalence (SE) between -1.25 diopters (D) and -13.75 D, at 12 cycles/degree for at least 3 months and at 18 cycles/degree for 1 week after LASIK. For patient eyes with SE between -1.25 D and -6.00 D, contrast sensitivity was depressed only at 12 cycles/degree for at least 3 months after LASIK. For patient eyes with SE between -6.00 D and -13.75 D, contrast sensitivity was depressed at 6, 12, and 18 cycles/degree 1 week after LASIK but returned toward preoperative levels by 1 month after surgery. Despite the slight decreases in contrast sensitivity, all scores were still within the range of normal values except for 12 cycles/degree for 3 months and 18 cycles/degree at 1 week after surgery in the high myopia group. Although highly myopic patients, compared with patients with low myopia, had slightly less BCVA before surgery, both groups maintained their preoperative BCVA at all postoperative visits. CONCLUSIONS: Based on this study, we conclude that LASIK has little effect on BCVA and contrast sensitivity for up to 3 months after surgery.

Photorefractive keratectomy versus laser in situ keratomileusis: comparison of optical side effects. Summit PRK-LASIK Study Group.

OBJECTIVE: This report presents patient-reported optical symptoms after photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK). DESIGN: Preoperative and postoperative patient surveys in a prospective, multicenter, randomized clinical trial. PARTICIPANTS: Two hundred twenty eyes of 220 patients entered the study; 105 were randomized to PRK and 115 were randomized to LASIK. INTERVENTION: All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure. Attempted corrections ranged from 6.00 to 15.00 diopters (D). MAIN OUTCOME MEASURES: Glare, halo, and monocular diplopia symptoms as reported by patients on questionnaires before surgery and at the 6-month follow-up. Comparison was made between symptoms when using optical correction before surgery and symptoms without correction after surgery. RESULTS: For both the PRK and LASIK groups analyzed individually, the difference in average glare index before surgery and after surgery was not statistically significant (P = 0.54 for PRK; P = 0.15 for LASIK; t test). Twenty-four PRK patients (41.4%) reported worsening of glare symptoms from baseline compared with 11 LASIK patients (21.6%); however, the difference between the two groups was not statistically significant (P = 0.086, chi-square test). Within the PRK group, the difference in average halo index before and after surgery was statistically significant (P = 0.0003, t test); in the LASIK group, it was not statistically significant (P = 0.1 1, t test). Thirty-four PRK patients (58.6%) reported worsening of halo symptoms from baseline compared with 26 LASIK patients (50.0%); this difference was not statistically significant (P = 0.086, chi-square test). For both the PRK and LASIK groups, the difference in average diplopia index before and after surgery was statistically significant (P < 0.0001 for PRK; 0.047 for LASIK; t test). Twenty-six PRK patients (44.8%) reported a worsening of monocular diplopia symptoms from baseline compared with 19 LASIK patients (35.8%); this difference was not statistically significant (P = 0.39, chi-square test). When changes in glare and halo from before surgery to after surgery were pooled as a glare-halo index, however, the PRK group did show a significantly greater likelihood of demonstrating an increase in symptoms compared with the LASIK group (P = 0.048, chi-square test). CONCLUSIONS: Optical sequelae of glare, halo, and monocular diplopia may occur in some patients after either both PRK or LASIK for moderate to high myopia; in contradistinction, many other patients' preoperative symptoms improve after surgery. On average, PRK patients show an increase in halo and diplopia symptoms, but not glare, after surgery, and LASIK patients show an increase in diplopia, but not glare and halo symptoms. There is a suggestion of a somewhat lesser tendency toward postoperative optical symptoms in LASIK compared with PRK treated eyes.

Comparison of ketorolac tromethamine, diclofenac sodium, and moist drops for ocular pain after radial keratotomy.

PURPOSE: To compare the 2 most popular commercially available topical nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of ocular pain following radial keratotomy (RK). SETTING: Multicenter clinical trial. METHODS: Ninety-seven RK patients were randomly assigned to 1 of 3 treatment groups: ketorolac tromethamine, diclofenac sodium, and moist drops as a control. The patients used 1 drop of the masked medication and 1 drop of ofloxacin 3 times a day for 3 days prior to surgery. They received 1 drop of the masked medication 1 hour before surgery, immediately after surgery, and 4 times a day thereafter. Patients were given a written questionnaire preoperatively and were also instructed to call a central computerized telephone system to answer prerecorded questions about ocular comfort. The calls were placed 30 minutes and 1, 2, 3, 4, 5, 6, 24, and 48 hours after surgery. RESULTS: Two hundred ten statistical values were calculated to compare symptoms in the unoperated eye at baseline with symptoms in the operated eyes at each of 9 postoperative time points. Only 7 of the 210 values (3.3%) were significantly different among patient groups (operated versus unoperated eyes) by psychometric testing. CONCLUSIONS: Both ketorolac tromethamine and diclofenac sodium were more effective in reducing post-RK discomfort than the control (moist artificial tears). Given the large number of tests and the small number that tested as significant, the significant differences (7 of 210 measurements) observed among the 3 treatment groups probably occurred by chance, although the improved foreign-body sensation, functionality, and compliance scores in the ketorolac group during the first 4 hours might be clinically important.

Efficacy and safety of nonpreserved ketorolac ophthalmic solution in postoperative ocular pain following radial keratotomy.

PURPOSE: To investigate the efficacy and safety of nonpreserved ketorolac tromethamine 0.5% ophthalmic solution in relieving pain following radial keratotomy (RK). SETTING: Multicenter clinical trial. METHODS: Topical ketorolac was compared with its vehicle in a double-masked, randomized, parallel-group study involving 170 RK patients. Patients were treated with nonpreserved ketorolac 0.5% ophthalmic solution or the vehicle 4 times daily beginning immediately after surgery and continuing for 3 days or until they no longer had ocular pain. RESULTS: At several intervals, patients treated with ketorolac reported significantly greater pain relief and less pain intensity than patients treated with the vehicle. The time required for patients to first report "complete relief" or "no pain" was shorter in the ketorolac than in the vehicle group (P < or = .006). Patients in the ketorolac group used less escape medication (acetaminophen) (P < or = .001) and had fewer sleep difficulties (P < or = .031), fewer symptoms of ocular discomfort (P < or = .028), and less difficulty performing activities of daily living (P = .048). Patients treated with ketorolac experienced the same low rate of treatment-related adverse events as those treated with the vehicle and exhibited the same improvement in visual acuity and manifest refraction. CONCLUSIONS: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, the vehicle in alleviating the postoperative pain associated with RK. This resulted in significant improvements in patient quality of life and less need for oral analgesics, suggesting that topical ketorolac is an appropriate treatment option for ocular pain following RK.

Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study.

OBJECTIVE: This report presents the results of a randomized clinical trial of photorefractive keratectomy (PRK) and laser-assisted in situ keratomileusis (LASIK). DESIGN: A randomized, prospective multicenter clinical trial. PARTICIPANTS: A total of 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. The mean preoperative manifest refraction spherical equivalent was -9.23 diopters (D) in the PRK group and -9.30 D in the LASIK group. INTERVENTION: All patients received a one-pass, multizone excimer laser ablation as part of either a PRK or LASIK procedure using the Summit Apex excimer laser. Attempted corrections ranged from 6.00 to 15.00 D. MAIN OUTCOME MEASURES: Data on uncorrected and spectacle-corrected visual acuity, predictability,and stability of refraction, corneal haze, and flap complications were analyzed. Patients were observed for up to 6 months. RESULTS: One day after surgery, 0 (0.0%) and 3 (4.5%) eyes in the PRK group saw 20/20 and 20/40 or better uncorrected, respectively, while 7 (10%) and 48 (68.6%) eyes in the LASIK group saw 20/20 and 20/40 or better, respectively. At 6 months after PRK, 13 (19.1%) and 45 (66.2%) eyes saw 20/20 and 20/40 or better, respectively, while after LASIK, 16 (26.2%) and 34 (55.7%) eyes saw 20/20 and 20/40 or better, respectively (odds ratio = 0.56 for likelihood of uncorrected visual acuity < 20/40 for PRK vs. LASIK, 95% confidence interval [CI] = 0.31-1.19). After PRK, 39 eyes (57.4%) were within 1.0 D of attempted correction compared with 24 eyes (40.7%) in the LASIK group (odds ratio = 0.50 for likelihood fo undercorrection 1.0 D for PRK vs. LASIK, 95% CI = 0.24-1.04); however, the standard deviation of the predictability was similar between groups: 1.01 D for PRK and 1.22 D for LASIK. From months 1 to 6, there was an average regression of 0.89 D in the PRK group and 0.55 D in the LASIK group. After PRK, eight eyes (11.8%) had a decrease in spectacle-corrected visual acuity of two Snellen lines or more; after LASIK, two eyes (3.2%) had a decrease of two lines or more (odds ratio = 3.89 for risk of loss of spectacle-corrected visual acuity for PRK vs. LASIK, 95% CI = 0.71-21.30). Only two eyes had postoperative spectacle-corrected visual acuity less than 20/32, however. CONCLUSIONS: Although improvement in uncorrected visual acuity is more rapid in LASIK than in PRK, efficacy outcomes in the longer term generally are similar between the two procedures. There is a greater tendency toward undercorrection in LASIK eyes using the specific laser and nomogram in this study, but the scatter in achieved versus attempted correction is similar, suggesting little difference in the accuracy of the two procedures. A suggestion of decreased propensity for loss of spectacle-corrected visual acuity in LASIK eyes requires further investigation.

Draping technique to isolate lashes and achieve maximum exposure.

A surgical draping technique is presented that decreases surgical time, maximizes surgical site exposure, and decreases the risk of infection. It was also designed to enhance patent comfort.

Long-term clinical results of AMO PhacoFlex model SI-18 intraocular lens implantation.

The AMO PhacoFlex Model SI-18 was the first commercially available three-piece silicone intraocular lens (IOL) for use in small incision cataract surgery. Allergan Medical Optics' silicone IOLs have been implanted in more than 750,000 patients worldwide over the past eight years. This report of the FDA clinical investigation of the AMO PhacoFlex model SI-18 IOL summarizes one year follow-up data from the initial premarket approval clinical trial on 500 core patients implanted with the SI-18 lens. One-year follow-up data from 5,860 patients in the modified core group and three-year follow-up data on the 500 patient core/modified core group are also presented. At three years postoperatively, 91.3% of best case core/modified core patients achieved 20/40 or better corrected visual acuity. Overall incidence of persistent complications at three years was 3.2%.

Photorefractive keratectomy for myopia using a 4.5-millimeter ablation zone.

BACKGROUND: Argon fluoride (193 nm) excimer laser photorefractive keratectomy for myopia is under evaluation by the United States Food and Drug Administration. METHODS: We report a consecutive prospective series of 100 patients (one eye per patient) treated as part of the Phase IIB FDA-approved protocol, with 80 patients followed for 1 year. Patients' ages ranged from 21 to 62 years (mean, 35 years). The Summit Technology, Inc ExciMed UV200LA with a 4.5-mm diameter ablation was used. RESULTS: Baseline spherical equivalent refraction ranged from -2.00 to -6.90 diopters (D) (mean -4.60 D). Ninety-five percent of eyes reepithelialized by 72 hours. At 1 year, the difference between attempted and achieved correction was +/- 0.50 D for 42 eyes (53%) and +/- 1.00 D for 60 eyes (75%). During the first 6 months, there was a trend toward overcorrection and the majority of eyes showed some loss of initial refractive correction; 10 eyes (14%) changed by 1.00 D or more between 6 and 12 months. An uncorrected visual acuity of 20/25 or better was achieved by 50 eyes (63%) and 20/40 or better by 61 eyes (77%). Of the 10 eyes (12%) that lost two or more Snellen lines of spectacle-corrected or glare visual acuity, two had visual acuity of worse than 20/25. Central subepithelial corneal haze was absent to mild in 77 (96%) eyes at 12 months. CONCLUSIONS: Excimer laser photorefractive keratectomy as performed in this study was generally effective and safe in reducing simple spherical myopia. Further studies of the effect of a larger diameter ablation zone, smoother transitional corneal contours, and the effect of postoperative topical corticosteroids may lead to further improvements in outcome.

Six-month results of the multicenter phase I study of excimer laser myopic keratomileusis.

We report six-month results of the Summit Technology Myopic Keratomileusis Phase I multicenter study. Fifty-seven eyes of 57 patients had keratomileusis to correct high myopia. A microkeratome was used for the primary keratectomy and the excimer laser was used to ablate the stroma of the resected lenticle (cap) or the stromal bed (in situ). At six months, 31 of the 47 eyes available for follow-up (65.9%) had uncorrected visual acuity of 20/40 or better; 16 (34.0%) had uncorrected acuity of 20/25 or better. Thirty-seven eyes (78.7%) maintained the same (+/- one Snellen line) best corrected visual acuity as before surgery; seven (14.9%) lost two lines and three (6.4%) lost more than two lines. In addition to the six-month multicenter study results, we report two year results in a subset of 28 eyes (22 from the multicenter study and six fellow eyes). At six months, 17 of the 24 eyes available for follow-up (70.9%) had uncorrected visual acuity of 20/40 or better and nine (37.5%) had uncorrected acuity of 20/25 or better, including eyes that had worse than 20/80 best corrected visual acuity preoperatively. At 24 months, five of the seven eyes available for follow-up (71.4%) had uncorrected acuity of 20/25 or better. Only one patient lost two lines of best corrected vision at six months and no patient lost more than two lines; at 24 months, all patients maintained (+/- one line) best corrected vision.(ABSTRACT TRUNCATED AT 250 WORDS)

A prospective, randomized, double-masked comparison of a zonal-progressive multifocal intraocular lens and a monofocal intraocular lens.

INTRODUCTION: Multifocal intraocular lenses (IOLs) have been designed to provide improved near visual acuity without spectacles compared with monofocal IOLs. Early studies have reported variables amounts of decreased visual acuity and contrast sensitivity with multifocal IOLs, and some patients have experienced halos and glare. METHODS: The authors performed a prospective, double-masked, multicenter evaluation of 62 patients randomized between a new zonal-progressive optic multifocal IOL and a monofocal IOL. RESULTS: Mean postoperative spherical equivalent, astigmatism, and uncorrected and best-corrected distance visual acuity were similar between the two groups. Patients with a multifocal IOL achieved significantly better uncorrected near visual acuity than patients with monofocal IOLs (J3+ versus J7; P less than 0.0001). With distance correction only, mean near visual acuity was J2 versus J5- (P = 0.0001). Best-corrected near visual acuity was J1 for both groups, with 1.36 diopters (D) for the multifocal group versus 2.37 D for the monofocal group (P less than 0.0001). Regan contrast sensitivity was lower for the multifocal patients at all contrast levels, and achieved statistical significance at very low contrast (11% contrast; P = 0.0024). Fifty-two percent of patients with a multifocal IOL reported that they did not need spectacles at all or used them only for their fellow eye, compared with 25% of the patients with monofocal IOLs. CONCLUSION: Both monofocal and multifocal implant patients were very satisfied with the results of their cataract extraction and IOL implant surgery. A small loss of contrast sensitivity with the multifocal IOL was demonstrated, consistent with theoretical predictions. The functional significance of the loss of contrast sensitivity appears to be small and counterbalanced by the advantage of improved uncorrected near visual acuity.

Prophylactic use of apraclonidine for intraocular pressure increase after Nd:YAG capsulotomies.

We evaluated the prophylactic effect of 1% apraclonidine HCl in controlling the increase in intraocular pressure after Nd:YAG posterior capsulotomy in a large, multicenter double-masked clinical trial. One hundred sixty-four patients were enrolled into the apraclonidine-treated group, and 165 into the vehicle-treated group. The incidence of increase in intraocular pressure (greater than 5 mm Hg) in the apraclonidine-treated group (7%, 11 of 163 patients) was significantly less than that in the vehicle-treated group (39%, 64 of 164 patients). Similarly, the mean maximal change in intraocular pressure in the apraclonidine-treated group (1.3-mm Hg decrease) was significantly different from the increase in the vehicle-treated group (5.3-mm Hg increase). Few adverse reactions were observed. The risk for significant loss of visual function after Nd:YAG laser posterior capsulotomy, combined with the efficacy and relative safety of prophylactic apraclonidine, suggest its addition to the treatment armamentarium.

Initial experience with the HydroSonics instrument to soften cataracts before phacoemulsification.

An ultrasonically driven needle placed into the body of the nucleus, with subsequent injection of balanced salt solution (BSS), can be used to fragment the nucleus into sections or lamellae that can potentially be emulsified with greater ease and less ultrasound energy delivered to the eye. This separation of the nucleus has been designated hydrodelineation. The six surgeons participating in this study subjectively reported that the use of hydrodelineation facilitated phacoemulsification, on average, in 91% of their cases. Review of study data indicated that significantly less ultrasound time and cumulative displayed energy were noted in phacoemulsification of grade 2+ and 3+ cataracts after hydrodelineation than in cases in which hydrodelineation was not performed. The results in cases performed with and without hydrodelineation were statistically equivalent in complications and postoperative patient outcomes.

The evolution of small-incision cataract surgery with foldable IOLs.

The use of phacoemulsification and soft foldable IOLs has decreased the incision size necessary to perform cataract surgery with implants. With this decreased incision size, significantly less surgically induced astigmatism is present, thus affording early visual rehabilitation and more rapid prescribing of postoperative spectacles. The evolution of this advanced technique and a review of small-incision lenses is presented. Their application in the everyday management of postoperative cataract patients by the practicing optometrist is stressed.

Astigmatism after small incision cataract surgery. A prospective, randomized, multicenter comparison of 4- and 6.5-mm incisions.

Four surgeons evaluated induced astigmatism and postoperative wound stability in a randomized prospective study of 130 patients undergoing cataract extraction. After phacoemulsification through a scleral pocket, patients received either a 6.5-mm diameter silicone optic posterior chamber intraocular lens (PC IOL) folded for insertion through a 4-mm small incision or a 6.0-mm diameter polymethylmethacrylate (PMMA) optic PC IOL placed through an approximately 6.5-mm conventional incision. Vector analysis calculations of prism diopters (D) of mean postoperative-induced keratometric astigmatism for the small incision versus conventional incision groups were, at day 1, 1.54 D versus 3.07 D (P less than 0.0001); at weeks 1 to 2, 1.00 D versus 2.43 D (P less than 0.0001); at 1 month, 0.98 D versus 1.44 D (P = 0.004); and at 3 months, 0.82 D versus 1.03 D (P = 0.089). Subgroup analysis of the suturing technique for the 6.5-mm incision showed that the technique of wound closure, as well as the wound size, influenced the induced astigmatism. For all four surgeons using three methods of suturing the 6.5-mm wound, however, the variability in the amount of induced cylinder was least with the 4.0-mm wound closed with a horizontal mattress suture. Complications in the two groups were comparable.

Keratometric cylinder and visual performance following phacoemulsification and implantation with silicone small-incision or poly(methyl methacrylate) intraocular lenses.

Silicone and poly(methyl methacrylate) (PMMA) intraocular lenses from Allergan Medical Optics were implanted in the posterior chamber of 96 cataract patients with small or standard incisions following phacoemulsification. Significantly less keratometric cylinder (astigmatism) and better uncorrected visual acuity were observed during the six week postsurgical follow-up in the patients who received the small incision silicone lens than in those who received the standard PMMA lens.