Faculty Bibliography

PURPOSE: Determine the degree of postoperative pain and rate of healing in eyes treated with either ketorolac tromethamine 0.4% (Acular LS) or nepafenac sodium 0.1% (Nevanac) after flapless surface ablation [epi-laser in situ keratomileusis (LASIK)]. METHODS: Prospective, randomized, double-masked, paired-eye comparison. Patients undergoing flapless surface ablation were randomized to receive ketorolac in 1 eye and nepafenac in the other. Drops were instilled immediately after the surgical procedure, and patients continued to instill the masked drops 3 times daily for 5 days. Study follow-up visits were at days 1 and 5 postoperatively. Patients were queried by phone regarding their level of pain at 5 hours postoperatively and on days 2, 3, and 4. Outcome measures included postoperative pain levels including need for additional rescue medications, rate of healing, and adverse events. RESULTS: Although the original target population was 60 eyes of 30 patients, this study was halted after only 14 eyes of 7 patients because of concern for patient safety, because most patients in 1 arm developed haze. Eyes treated with nepafenac healed at a slower rate than eyes treated with ketorolac in 57% of patients. Mean time to healing was 5.7 +/- 1.1 days with ketorolac and 7.9 +/- 2.1 days with nepafenac (P = 0.066). Moreover, eyes treated with nepafenac exhibited statistically significant greater mean hazing scores at week 2 (P = 0.024) and month 1 (P = 0.039). Throughout the study, a greater percentage of nepafenac-treated eyes exhibited haze than did ketorolac-treated eyes. This difference was statistically significant at week 2 (P = 0.005) and month 1 (P = 0.039). Patients reported significantly more pain in nepafenac-treated eyes at day 3 when pain was at its peak (P = 0.046). CONCLUSIONS: In patients undergoing epi-LASIK, a statistically significant trend postoperative toward increased corneal haze was seen with nepafenac compared with ketorolac. Nepafenac therapy resulted in a non-statistically significant trend toward delayed healing. The study was halted because of safety concerns

PURPOSE: To evaluate dry-eye signs, symptoms, and refractive outcomes in patients with dry-eye disease having laser in situ keratomileusis (LASIK). METHODS: In this randomized parallel double-masked prospective clinical trial, 42 eyes of 21 myopic patients (mean spherical equivalent -4.3 diopters [D], range -1.00 to -10.63 D) with dry-eye disease were treated with unpreserved artificial tears or cyclosporine 0.05% ophthalmic emulsion twice a day beginning 1 month before LASIK. Treatment with the study drug was discontinued for 48 hours post surgery and then resumed for 3 additional months. Both groups used additional artificial tears as needed. Study visits occurred pretreatment (baseline), before surgery, and at 1 week and 1, 3, 6, and 12 months after surgery. RESULTS: Statistically significant increases from baseline were found in Schirmer scores for artificial tears at 1 month (P = .036) and for cyclosporine 0.05% before surgery and 1 week, 1 month, and 6 months after surgery (P<.018). There were no significant differences from baseline or between groups in responses to the Ocular Surface Disease Index questionnaire or best corrected visual acuity (BCVA), nor were there significant between-group differences in superficial punctate keratitis or uncorrected visual acuity. Mean refractive spherical equivalent in cyclosporine-treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial-tears-treated eyes (P = .007). A greater percentage of cyclosporine eyes was within +/-0.5 D of the refractive target 3 months after surgery than artificial tears eyes (P = .015). CONCLUSION: Successful outcomes after LASIK were achieved for dry-eye disease patients. Treatment with cyclosporine 0.05% provided greater refractive predictability 3 and 6 months after surgery than unpreserved artificial tears

PURPOSE: To determine the safety and efficacy of levofloxacin 1.5% eyedrops. SETTING: Tulane University Delta Research Primate Center, New Orleans, Louisiana, USA. METHODS: Ten monkeys had preoperative slitlamp examinations, photographs, and confocal microscopy. Levofloxacin 1.5% or control eyedrops were given 4 times a day in both eyes for 2 days and every 5 minutes for the hour before surgery and 4 times a day in both eyes for 1 week. Confocal microscopy, slitlamp examination, and slitlamp photography were repeated preoperatively. Intraoperative aqueous humor and corneal biopsies were taken. RESULTS: There were no differences between groups in slitlamp examinations, slitlamp photography, confocal microscopy, or histology; the mean levofloxacin level in the aqueous humor was 4.49 mug/mL +/-1.59 SD and in the corneal biopsies, 103.85 +/- 51.48 mug/g. CONCLUSION: Levofloxacin 1.5% drops given on a typical perioperative schedule to monkeys having penetrating keratoplasty showed no clinical or histological signs of toxicity and reached corneal issue levels well over the minimum inhibitory concentrations for all known ocular pathogens

PURPOSE: To evaluate the data on the safety, effectiveness, and stability of conductive keratoplasty (CK), a thermal, radiofrequency-based technique for treating 0.75 to 3.00 diopters (D) of spherical hyperopia. METHODS: A prospective, consecutive series, multicenter clinical trial involving 400 hyperopic eyes was conducted by 19 surgeons at 12 centers. The treatment goal was emmetropia. Cohort follow-up was up to 2 years. RESULTS: At 12 months postoperatively, data were available for 97.5% (354/363) of eyes for efficacy variables and 98% (391/400) of eyes for safety variables. A total of 54% of the CK eyes showed 20/20 or better uncorrected visual acuity, and 92% showed 20/40 or better at 12 months. The mean postoperative manifest refractive spherical equivalent was within 0.50 D in 61% and within 1.00 D in 88%. After CK, eyes were approximately 0.50 D myopic at month 1 and effectively emmetropic at 6 months. At 24 months, there was a 20% loss of initial effect. Safety results showed a 2-line loss of best-corrected visual acuity in 2% of the CK-treated eyes. The incidence of induced cylinder of 2.00 D or greater was below 1%. CONCLUSION: The CK technique corrects low to moderate hyperopia effectively and safely and with acceptable stability. It spares the visual axis, does not require the creation of a large flap, and is not associated with postoperative dry eye. CK has value as an alternative to hyperopic LASIK for patients with hyperopia

PURPOSE: To provide 6-month results of a 1-year clinical trial evaluating conductive keratoplasty (CK) for the treatment of presbyopic symptoms in emmetropic and hyperopic eyes. METHODS: A total of 143 patients with presbyopic symptoms were enrolled in this 1-year United States FDA clinical trial and treated to improve near vision in 1 eye (unilateral treatment). In addition, 33 fellow eyes were treated to improve distance vision (bilateral treatment). For near vision correction, the target refraction was up to -2.0 D in the nondominant eye, and for distance vision correction, 0.0 D. Enrolled patients had a preoperative spherical equivalent of plano to +2.00 D, no more than 0.75 D of refractive astigmatism, and were 40 years of age or older. No retreatments were performed. RESULTS: Of the eyes treated for near, 77% had uncorrected near vision of J3 or better at 6 months postoperatively. A total of 85% of all patients had binocular distance UCVA of 20/25 or better along with J3 or better near, a combination that represents functional acuity for a presbyope. Sixty-six percent of eyes treated for near had a manifest refractive spherical equivalent (MRSE) within +/- 0.50 D of intended at 6 months. In 89% of eyes, the MRSE changed 0.05 D or less between 3 and 6 months postoperatively. After month 1, the incidence of variables associated with safety was 1% or lower. Seventy-six percent were very satisfied or satisfied with their procedure. CONCLUSIONS: CK appears to be very safe and effective in producing functional visual acuity in presbyopic eyes up to 6 months following the procedure. Patient satisfaction with the procedure is similar to that of monovision LASIK

OBJECTIVE: To document the 1-year safety, efficacy, and stability results of 355 eyes treated in the multicenter study of conductive keratoplasty (CK) used to correct low to moderate hyperopia. DESIGN: Nonrandomized comparative (self-controlled) trial. PARTICIPANTS: Twenty surgeons at 13 centers performed CK on the eyes of all patients enrolled in a multicenter, 2-year, U.S. phase III clinical trial. Treated eyes had +0.75 to +3.00 diopters (D) of hyperopia and < or =0.75 D of cylinder. Patients were 40 years of age or older. INTERVENTION: Low-energy, high-frequency current was applied directly into the peripheral corneal stroma through a delivery tip inserted at 8 to 32 treatment spots. The number of treatment spots was increased for increasing levels of hyperopia, but the amount of radiofrequency energy remained constant. Emmetropia was intended. All eyes were treated once (there were no retreatments). MAIN OUTCOME MEASURES: Data from 355 eyes with 1 year of follow-up were analyzed for safety and stability, and data from 318 eyes were analyzed for efficacy and predictability, as well as stability and safety. All patients reported on satisfaction and quality of vision after surgery. RESULTS: At 1 year, uncorrected visual acuity was < or =20/20 in 56%, < or =20/25 in 75%, and < or =20/40 in 92% of eyes. The manifest refractive spherical equivalent refraction was within 0.50 D in 63%, within +/-1.00 D in 89%, and within +/-2.00 D in 99%. Seven of 355 eyes lost 2 lines of best spectacle-corrected visual acuity at 1 year, but no eye lost >2 lines. One eye of 355 had induced cylinder of >2.00 D. The cycloplegic refractive spherical equivalent changed a mean of 0.25 +/- 0.50 D between months 3 and 6, 0.11 +/- 0.41 D between months 6 and 9, and 0.11 +/- 0.35 D between months 9 and 12. Refractive stability seemed to be attained by 6 months and remained stable through 12 months. Histology and confocal microscopy showed deep penetration of the treatment into the stroma. Endothelial cell counts were not changed by the treatment. CONCLUSIONS: CK seems to be safe, effective, and stable for correcting low to moderate spherical hyperopia in patients 40 years old or older. Treatment penetration is deep and cylindrical in shape, and it does not damage the corneal endothelium. Uncorrected visual acuity, predictability, and stability are as good as or better than those obtained with other techniques used to correct hyperopia