Stephen F. Brint

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.

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.

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.

Results of Phase III Excimer Laser Photorefractive Keratectomy for Myopia

OBJECTIVE The purpose of the study is to determine safety and efficacy outcomes of excimer laser photorefractive keratectomy (PRK) for the treatment of mild-to-moderate myopia. DESIGN A prospective, multicenter, phase III clinical trial. PARTICIPANTS A total of 701 eyes of 701 patients were entered in the study; 612 eyes were examined at 2 years after surgery. INTERVENTION Intervention was photorefractive keratectomy using the Summit ExciMed UV200LA excimer laser (Summit Technology, Inc., Waltham, MA). The treatment zone diameter used was 4.5 mm in 251 eyes (35.8%) and 5 mm in 450 eyes (64.2%). Attempted corrections ranged from 1.50 to 6.00 diopters (D). MAIN OUTCOME MEASURES Predictability and stability of refraction, uncorrected and spectacle-corrected visual acuity, refractive and keratometric astigmatism, corneal haze, contrast sensitivity, subjective reported problems of glare and halo, and patient satisfaction were the parameters measured. RESULTS At 2 years, 407 (66.5%) eyes achieved 20/20 or better uncorrected visual acuity and 564 (92.5%) eyes achieved 20/40 or better visual acuity. Three hundred thirty-six (54.9%) eyes were within 0.5 D and 476 (77.8%) eyes were within 1.0 D of attempted correction. Stability of refraction improved with time; 86.8% of eyes were stable within 1.0 D from 6 to 12 months, 94% were stable from 12 to 18 months, and 96.3% were stable from 18 to 24 months. There was no evidence of progressive or late myopic or hyperopic refractive shifts. One hundred fourteen (18.6%) eyes gained 2 or more lines of spectacle-corrected visual acuity, whereas 42 (6.9%) eyes lost 2 or more lines; however, of the latter, 32 (76.2%) had spectacle-corrected visual acuity of 20/25 or better and 39 (92.9%) eyes had 20/40 or better. Four hundred forty-two (72.2%) corneas were clear, 138 (22.5%) showed trace haze, 20 (3.3%) mild haze, 9 (1.5%) moderate haze, and 3 (0.5%) marked haze. On patient questionnaires, 87 (29.7%) patients reported worsening of glare from preoperative baseline; 133 (50.1%) reported worsening of halo symptoms from baseline. CONCLUSIONS Photorefractive keratectomy appears effective for myopic corrections of -1.50 to -6.00 D. Uncorrected visual acuity is maximized in most eyes by 3 months, although some patients require between 6 months and 1 year to attain their best postoperative uncorrected visual acuity and some may require from 1 to 2 years for stabilization of refraction. Refraction stabilizes progressively without evidence of late myopic or hyperopic refractive shifts. Optical sequelae of glare and halo occur in some patients treated with a 4.5- or 5-mm treatment zone.

Corneal Topography of Phase III Excimer Laser Photorefractive Keratectomy: Characterization and Clinical Effects

PURPOSE To define qualitative patterns of corneal topography after excimer laser photorefractive keratectomy (PRK), assess changes in patterns, associations with clinical outcomes, and the accuracy of videokeratography in predicting results, and define quantitatively the optical zone contour. METHODS Computer-assisted videokeratography data obtained from 181 patients after PRK was analyzed. Topography patterns at two time points were characterized, and associations with clinical outcomes were tested. Power change predicted by topography was compared with refractive change, and cross-sectional power contours were analyzed. RESULTS Seven topography patterns were defined. At 1 year, 58.6% of corneas showed a homogeneous topography, 17.7% showed a toric-with-axis configuration, 2.8% showed a toric-against-axis configuration, 13.8% showed an irregularly irregular topography, 2.8% showed a keyhole/semicircular pattern, and 4.4% showed focal topographic variants. No central island patterns were found. Of the maps, 41% changed over time. Uncorrected vision, predictability, and patient satisfaction were best in the homogeneous group. Astigmatism increased in the irregular and toric-against-axis groups and decreased in the toric-with-axis group. There was no relation of topography pattern to best-corrected vision or subjective glare/halo. Cross-sectional power profiles showed a homogeneous power change for the central 3 mm with a diminution in correction toward the periphery. The topography unit tended to overestimate refractive change for corrections of 5 diopters or less and underestimate the change for corrections greater than 5 diopters. CONCLUSIONS Topography patterns after PRK are identifiable, time dependent, and may affect clinical outcomes. Understanding the actual corneal optical contour resulting from PRK may aid in improving both laser techniques and optical results in the future.

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.

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

ABSTRACT 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.

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.

A Multicenter Trial of Photorefracti*ve Keratectomy for Residual Myopia after Previous Ocular Surgery

Purpose: The Summit Therapeutic Refractive Clinical Trial is a nine-center prospective, nonrandomized, self-controlled trial to assess the efficacy, stability, and safety of using a standardized technique of excimer laser photorefractive keratectomy (PRK) to correct residual myopia in eyes with previous refractive surgery or cataract surgery. Patients and Methods: Eligible eyes with a mean residual myopia of -3.7 ± 1.8 diopters (D) (range, -0.63 to -11.00 D) underwent PRK with a 193-nm excimer laser for myopic corrections between -1.50 and -7.50 D. Standardized settings were used for the ablation zone, ablation rate, repetition rate, and fluence. One hundred seven of the first 114 treated eyes were examined 1 year after PRK, with 98% of eyes having had refractive keratotomy and 2% having had cataract surgery. Results: One year postoperatively, the mean manifest spherical equivalent refraction was -0.6 ± 1.4 D (range, -6.50 to 2.50 D); 63% of eyes were within ±1.00 D of the attempted correction; and uncorrected visual acuity was 20/40 or better in 74% of eyes. Twenty-nine percent of eyes lost two or more Snellen lines of best-corrected visual acuity, and central corneal haze was moderate or severe in 8% of eyes. Conclusion: Excimer laser PRK is effective in reducing residual myopia after previous refractive and cataract surgery. However, it is less accurate than PRK in eyes that did not undergo surgery and is more likely to cause a loss of best-corrected visual acuity 1 year after treatment.

Six-month results of the Multicenter Phase I Study of Excimer Laser Myopic Keratomileusis

Abstract 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. Our findings suggest that myopic keratomileusis performed with the microkeratome, using the excimer laser for the refractive cut, is a safe, effective, and relatively predictable way to correct high myopia in the 6.0 to 25.0 diopter range. With longer follow‐up, the accuracy of the refractive correction, as well as best corrected visual acuity and uncorrected visual acuity, continues to improve.