A multicenter comparison of the ocular efficacy and safety of diclofenac 0.1% solution with that of ketorolac 0.5% solution in patients with acute seasonal allergic conjunctivitis.

Only one of several available ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) is currently FDA approved for use in acute seasonal allergic conjunctivitis (SAC). Sixty patients with SAC and moderate itching and bulbar conjunctival injection were enrolled in a multicenter, randomized, double-masked, parallel-group trial comparing diclofenac sodium (DS) with ketorolac tromethamine (KT). Patients instilled 1 drop four times daily while awake for 14 days. Ocular signs and symptoms were evaluated at one and two weeks. The primary efficacy variables were itching and bulbar conjunctival injection. For both treatments, the ocular allergy sign and symptom scores were comparable at baseline. Both treatments evaluated in this study were well tolerated. Significant clinical and statistical reductions from baseline were observed in the primary efficacy variables. Treatment group differences were observed for the pain/soreness score with an advantage observed for the DS group at 30 minutes and at day 7. Our conclusion is that diclofenac sodium and ketorolac tromethamine acted similarly to reduce the ocular signs and symptoms associated with acute seasonal allergic conjunctivitis. There was a statistically significant advantage for the DS group to be free of symptoms at the day 7 visit as compared to the KT group (20.7% vs. 3.2%).

Two-year safety study of dorzolamide as monotherapy and with timolol and pilocarpine. Dorzolamide Safety Study Group.

PURPOSE: To evaluate the safety of open-label 2.0% dorzolamide as monotherapy and when used with timolol and/or pilocarpine for as long as 2 years. METHODS: The safety of dorzolamide was evaluated in patients with open-angle glaucoma or ocular hypertension over a 2-year period. The incidence of the most common drug-related adverse experiences in the first year was compared with that in the second year using McNemar's test. The ocular hypotensive effect of dorzolamide as monotherapy and with adjunctive therapy was assessed using percent change in intraocular pressure (IOP) from baseline. RESULTS: Of the 304 patients enrolled, 164 (53.9%) continued to receive dorzolamide as monotherapy for 2 years and 140 (46.1%) required add-on therapy. Add-on therapy was initiated by month 6 in 112 of these 140 patients (80%). Of the 304 patients, 202 (66.4%) completed 2 years of therapy. Of the patients who received dorzolamide as monotherapy, drug-related adverse events occurred more frequently during the first year (29.7%) than the second year (13.8%), and the most common ocular drug-related adverse events included conjunctivitis, burning/stinging eye, follicular conjunctivitis, and eyelid edema. After 2 years of therapy, the mean percent decrease in peak IOP was 22.8% for patients receiving dorzolamide monotherapy and 31.2% to 36.0% for patients receiving add-on therapy. CONCLUSION: Dorzolamide was generally well tolerated for up to 2 years as monotherapy and when used with timolol and/or pilocarpine. Drug-related adverse events were less frequent during the second year of monotherapy than during the first year. Most patients who required add-on therapy did so within the first 6 months of initiating dorzolamide therapy.

Ketorolac, prednisolone, and dexamethasone for postoperative inflammation.

This 6-week, partially masked, three-arm, multicenter study was conducted to evaluate the postoperative anti-inflammatory efficacy of ketorolac, a cyclooxygenase inhibitor. The study setting was the clinical practice of six ophthalmic surgeons. The study enrolled 157 candidates for routine extracapsular cataract extraction or phaco-emulsification and posterior-chamber intraocular lens implantation. Patients who received any glucocorticoid or cyclooxygenase inhibitor within 1 week of surgery were excluded. All patients were treated with solutions of 0.5% ketorolac, 1% prednisolone acetate, or 0.1% dexamethasone instilled into the operative eye three times daily from 1 day before surgery to 4 weeks after surgery. Efficacy variables included the signs of anterior-segment inflammation, primarily cells and flare in the anterior chamber, as observed by slit-lamp biomicroscopy; fluorescein leakage across the blood-aqueous barrier as measured by fluorophotometry; and the rating of efficacy by the investigator. No significant differences were seen between ketorolac and either glucocorticoid in cells and flare. No significant differences were found in other signs of inflammation, except conjunctival hyperemia and Descemet's folds at week 2. Ketorolac showed significantly greater efficacy than the glucocorticoids against blood-aqueous barrier breakdown at day 5 and week 2, as demonstrated by the difference in fluorescein concentration between the operated and nonoperated eyes. Investigators did not detect any significant difference in rating for overall effectiveness and acceptability. These findings support the use of ketorolac as an alternative to glucocorticoids for the treatment of postoperative inflammation.

Results one year after using the 193-nm excimer laser for photorefractive keratectomy in mild to moderate myopia.

As part of a clinical trial, photorefractive keratectomy using the VISX 2015 193-nm excimer laser was performed on 91 healthy eyes of 91 patients. Preoperative refractive errors (spherical equivalent) ranged from -1.00 to -7.50 diopters (mean, -4.16 +/- 1.41 diopters). No patient had more than 1 diopter of refractive astigmatism. Six months postoperatively, the average residual refractive error was +0.09 +/- 0.63 diopters (range, -2.13 to +1.63 diopters). Correction within 1 diopter of that attempted was attained in 85 eyes (93%). Uncorrected visual acuity of 20/40 or better was attained in 86 eyes (95%) and was 20/25 or better in 67 eyes (74%). At one year, follow-up information was available on 85 eyes of 85 patients. The average residual refractive error was -0.15 +/- 0.65 diopters (range, -2.50 to +1.63 diopters). Correction within 1 diopter of that attempted was attained in 85 eyes (93%). Uncorrected visual acuity was 20/40 or better in 83 eyes (98%) and was 20/25 or better in 68 eyes (80%). One patient lost three lines of best-corrected visual acuity because of corneal haze, dropping from 20/15 to 20/30, whereas all other patients returned to best-corrected visual acuity within one line of their preoperative best-corrected visual acuity. Photorefractive keratectomy with the 193-nm excimer laser appears to be a useful treatment modality for the reduction of mild to moderate myopia.

193-nm excimer photorefractive keratectomy in high myopia.

PURPOSE: To evaluate the refractive results of 193-nm excimer laser photorefractive keratectomy (PRK) performed on 48 highly myopic eyes in a multicenter study. METHODS: A Visx 2015 or 2000 argon-fluoride excimer laser and a single-zone ablation technique were used. Postoperatively, eyes were treated with topical fluoromethalone for up to 5 months. Most eyes were treated with a 6.0- to 6.2-mm beam diameter after undercorrections and increased regression were noted with a 5.5-mm beam in earlier studies. Forty-eight eyes were treated for myopia, which was between -8.0 and -15.25 diopters (D) (spherical equivalent). The mean preoperative refraction was -11.2 D. Retreatment was performed after 6 to 16 months on 11 eyes for undercorrection. All eyes not retreated were followed for at least 12 months. RESULTS: At 6 months, follow-up was available on 47 eyes. Of these eyes, 40% and 64% achieved corrections within 1 and 2 D of attempted correction, respectively. At 1 year, 60% of eyes attained 20/40 visual acuity or better uncorrected. Eleven patients (23%) were retreated between 6 to 16 months for undercorrection and/or regression. After retreatment, 47% and 81% of eyes achieved corrections within 1 and 2 D of attempted correction, respectively. At 1 year, 15% of eyes lost two lines of best-corrected visual acuity, and no eyes lost more than two lines. There was slightly more corneal haze seen in this group compared with the haze seen in patients undergoing PRK for low and moderate myopia. CONCLUSIONS: These data show that excimer PRK can correct high amounts of myopia with reasonable stability after 6 months. Excimer PRK is an effective surgical treatment of severe myopia, but long-term follow-up is still needed to assess the stability of its effect.

Use of the 193 nm excimer laser for photorefractive keratectomy in low to moderate myopia.

As part of a Phase III clinical trial, photorefractive keratectomy using the VISX 2015 193 nm excimer laser was performed on 91 sighted eyes of 91 patients. Preoperative refractive errors (spherical equivalent) ranged from -1.00 diopters (D) to -7.50 D (mean -4.11 D +/- 1.43 D). At six months, average residual refractive error was 0.02 D +/- 0.64 D (range -2.21 D to +1.38 D). Ninety-three percent of eyes were within 1.00 D of attempted correction, 93% had uncorrected visual acuity of 20/40 or better, and 72% achieved uncorrected visual acuity of 20/25 or better. All patients returned to their best corrected visual acuity within one line of their preoperative best corrected visual acuity. Photorefractive keratectomy with the 193 nm excimer laser appears to be useful in reducing low to moderate myopia.

Topical diclofenac in the treatment of ocular pain after excimer photorefractive keratectomy.

BACKGROUND: Following excimer laser photorefractive keratectomy, patients experience significant ocular pain until corneal reepithelialization. Despite the use of cold compresses, bandage soft contact lenses, cycloplegics, narcotics, and topical corticosteroids, the pain has not been adequately controlled in many patients. METHODS: A randomized, double-masked, parallel-group study of diclofenac sodium 0.1% ophthalmic solution and its placebo vehicle was evaluated. Patients undergoing excimer myopic photorefractive keratectomy on their second eye were admitted overnight. Postoperative procedures included two drops of diclofenac or placebo immediately after surgery and then qid until reepithelialization, topical tobramycin (qid), 0.1% fluorometholone (q2h), cycloplegics, and a disposable soft contact lens. Thirty-two patients (diclofenac = 16, placebo = 16) were evaluated from +30 minutes to +96 hours by several types of questionnaires. RESULTS: Most patients who received placebo experienced pain, starting within 1 hour, peaking at 4 to 6 hours and lasting 36 to 48 hours. The diclofenac-treated patients rarely experienced the early peak in pain, had less pain overall until 72 hours postoperatively, and experienced significantly less photophobia and burning/stinging. Significantly fewer patients on diclofenac required oral narcotics. Three patients (diclofenac = 2, placebo = 1) developed corneal infiltrates, the etiology of which is not known. In a separate study we conducted, there was no difference in epithelial healing times between the diclofenac-treated eyes and those not receiving the drug. CONCLUSIONS: Diclofenac appears to significantly reduce the ocular pain following excimer photorefractive keratectomy.

A comparison of the ocular hypotensive efficacy of twice-daily 0.25% levobunolol to 0.5% timolol in patients previously treated with 0.5% timolol.

Treatment with noncardioselective beta-adrenoceptor antagonists (e.g., 0.5% timolol or 0.5% levobunolol) is standard practice for lowering elevated intraocular pressure (IOP). However, because there are risks and side effects associated with the use of these agents, a lower, yet still effective, dose may be preferred. We gave 0.5% timolol twice daily for 30 days to 143 patients. In a double-masked, randomized fashion, we then assigned patients to continue to receive 0.5% timolol twice daily or 0.25% levobunolol twice daily for 8 weeks. The mean unmedicated baseline IOP for both groups was approximately 25 mm Hg. After 30 days of timolol pretreatment, the mean IOP in both groups decreased to approximately 19 mm Hg (p = 0.210). After the 30-day timolol pretreatment period, and subsequent randomization to either 0.5% timolol or 0.25% levobunolol treatment, there was little change in overall mean IOP (0.03 mm Hg decrease for levobunolol, 0.06 mm Hg increase for timolol; p = 0.811) from the timolol pretreatment baseline. One patient assigned to the timolol treatment group was terminated from the study due to inadequate control of IOP. We conclude that the mean IOP lowering effect of 0.25% levobunolol is equivalent to 0.5% timolol, and switching patients from twice-daily 0.5% timolol to twice-daily 0.25% levobunolol poses no significant risk of decreased ocular hypotensive efficacy.

The use of the 193-nm excimer laser for myopic photorefractive keratectomy in sighted eyes. A multicenter study.

Photorefractive keratectomy was performed at three centers using the 193-nm excimer laser on 31 sighted myopic eyes. Preoperative refractive errors (spherical equivalent) ranged from -12.00 to -4.00 diopters (D) (mean, -6.49 +/- 1.75 D). Peribulbar anesthesia, a 5.2- to 6.0-mm beam diameter, and topical corticosteroids were used for up to 6 months after surgery. The epithelium healed within 3 to 4 days, and all patients returned to their best corrected visual acuity within 1 line of their preoperative acuity. There was minimal subepithelial reticular haze, peaking at 3 weeks and diminishing over the next 3 to 4 months, which was not felt to be visually significant. At 6 months, the average residual refractive error was -1.85 +/- 2.5 D. Sixty-eight percent of eyes were corrected within 2 D and 55% within 1 D of attempted correction. There was no significant change in astigmatism, contrast sensitivity, corneal sensation, or endothelial cell counts. This preliminary work shows that photorefractive keratectomy has promise in the reduction of moderate myopia.

Myopic excimer laser keratectomy: a preliminary report.

Six patients underwent excimer laser refractive keratectomy for the correction of myopia. All eyes, with the exception of patient 6, who underwent a previous failed epikeratophakia procedure and subsequent removal of the lenticule, had normal baseline ophthalmologic evaluations and best corrected visual acuities of 20/25 or better. Spherical equivalents ranged between -5.50 and -12.00 diopters. Under topical and peribulbar anesthesia, the central corneal epithelium was removed. The delivery system of the laser was programmed to ablate corrections onto the central 5.0 mm of the cornea that would result in approximate emetropia. Moderate fluctuation of refractive and topographic parameters was noted during the period of epithelial healing and remodeling. At the 12th postoperative week, five of the corneas were clear on biomicroscopic evaluation with best corrected acuities of 20/20. The final patient, who was noncompliant in the use of topical corticosteroid therapy, developed a central, 2-mm opacity and resulting best corrected acuity of 20/40. Overall, the group demonstrated that myopic excimer laser photorefractive keratectomy is consistent with good wound healing, insignificant corneal scarring, a stable refractive correction, and excellent visual acuity.