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Purpose: To evaluate the safety, efficacy, and pharmacokinetics of pilocarpine hydrochloride 1.25% (Pilo hereafter) compared with vehicle when administered bilaterally, twice daily (6 hours apart) for 14 days in participants with presbyopia., Design: Phase 3, randomized (1:1), controlled, double-masked, multicenter study., Methods: Participants (40-55 years of age) had objective and subjective evidence of presbyopia affecting daily activities with mesopic, high-contrast, binocular distance-corrected near visual acuity (DCNVA) of 20/40 to 20/100. The primary/key secondary endpoint was the proportion of participants gaining ≥3 lines in mesopic/photopic, high-contrast, binocular DCNVA on day 14 (last study visit), hour 9 (3 hours after the second dose), with no more than a 5-letter loss in mesopic/photopic corrected distance visual acuity with the same refractive correction. Key safety measures included treatment-emergent adverse events (TEAEs) and some ocular measurements. Pilocarpine plasma levels were assessed in approximately 10% of enrolled participants., Results: Overall, 230 participants were randomized to Pilo twice daily (N = 114) and vehicle (N = 116). The proportion of participants achieving the primary and key secondary efficacy endpoints was statistically significantly greater with Pilo twice daily than vehicle, with between-treatment differences of 27.3% (95% CI = 17.3, 37.4) and 26.4% (95% CI = 16.8, 36.0), respectively. The most common TEAE was headache, reported in 10 participants (8.8%, Pilo group) and 4 participants (3.4%, vehicle group). Pilocarpine's accumulation index on day 14 was ≤1.11 after the second dose., Conclusions: Near-vision improvements were statistically greater with Pilo twice daily than with vehicle, without compromising distance acuity. The safety profile of Pilo twice daily was consistent with that of Pilo once daily, and systemic accumulation was minimal, supporting twice daily administration., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the effect of age and pupillary dilation on aqueous flare., Methods: In this study, 100 eyes of 100 patients ranging in ages from 23 to 84 years were examined. Anterior chamber flare was measured before and after pupillary dilation using the Kowa laser flare meter (FM-500). Predilation and postdilation flare counts were compared by paired t-test. Stepwise regression analysis was then used to determine the effect of demographic variables on pre- and postdilation flare as well as the difference between pre-and postdilation flare counts., Results: The predilation and postdilation flare counts correlated with age (P < 0.0001 for both pre-and postdilation flare counts). Correlation coefficient between age and flare measurements was R2 = 0.58 predilation and 0.63 postdilation. Flare intensity significantly decreased after pupillary dilation (P < 0.001)., Conclusions: Anterior chamber flare increases with age. It might be related to blood-aqueous barrier instability. Pupillary dilation significantly decreases flare counts suggesting that aqueous protein concentration is dependent on aqueous flow rates.

Purpose: To determine the presence of anterior chamber flare and cells after laser in situ keratomileusis (LASIK) for the correction of myopia., Setting: Hermann Eye Center and the University of Texas Medical School, Department of Ophthalmology and Visual Science, Houston, Texas, USA., Methods: Forty-three eyes of 23 consecutive patients ranging in age from 24 to 62 years had LASIK for myopia. All surgeries were performed by a single surgeon using a VISX Star laser and the same technique. Patients received no preoperative antiinflammatory medications. Postoperatively, all patients were instructed to use 1 drop of ofloxacin (Ocuflox) and 1 drop of fluorometholone 0.1% (FML) in the operated eye 4 times daily while awake for 7 days. At baseline and postoperative days 1, 7, and 28, anterior chamber flare was measured and cells were counted using a Kowa laser flare meter (FM-500) and laser cell counter (LC-500), respectively., Results: Flare and cells increased significantly on day 1 (P <.0001 for both flare and cells) and returned to preoperative levels by day 7. No statistically significant correlation was detected between the amount of inflammation and the number of laser pulses (P =.2922) or the ablation time (P =.8383)., Conclusions: A significant increase in anterior chamber inflammation occurred during the first 24 hours after LASIK. Inflammation levels then subsided to preoperative levels by day 7 with steroid use. Anterior chamber inflammation did not appear to correlate with the duration of the ablation or the number of laser pulses.

Postoperative ocular inflammation following cataract surgery is related to the risk of complications like corneal edema, intraocular pressure spikes, cystoid macular edema, and posterior capsule opacification. The degree of postoperative inflammation following cataract surgery is linked to several surgery-dependent factors such as surgical technique, intraocular lens type, and also patient-dependent factors such as history of inflammatory disease and degree of iris pigmentation. During the past decade, major advances have occurred in cataract surgery techniques, equipment, and pharmacologic strategies that decrease the degree of postoperative inflammation following cataract surgery and reduce patients' risk for inflammation-related complications. This article reviews the most recent literature regarding the control of cataract surgery-induced intra-ocular inflammation.

Purpose: To describe a new technique for revising oversized blebs after trabeculectomy., Methods: A chart review of consecutive patients undergoing bleb window cryopexy was conducted. Patients with symptomatic oversized blebs were candidates for the technique, regardless of the intraocular pressure. Under topical anesthesia, the bleb was incised and a 3 mm x 3 mm conjunctival window was removed using 0.12 forceps and Vannas scissors. Light cryotherapy was applied to the sclera through the window. A soft bandage contact lens was then placed for compression, and a patch was applied. All patients were given antibiotic drops the first day after surgery. Topical corticosteroid drops were used to minimize postoperative inflammation. Outcome measures included relief of symptoms, adequate control of intraocular pressure, and restoration of filtering bleb function without further antiglaucoma medication or surgical bleb revision., Results: Nine patients met the inclusion criteria. All patients had flattening of the bleb with symptomatic relief within 2 weeks. No loss of bleb function occurred. One patient developed aqueous misdirection after the procedure., Conclusion: Early results showed that bleb window cryopexy is safe and effective. This minimally invasive technique can be useful for selected patients with large. symptomatic, overhanging blebs.

Purpose: To compare the efficacy of 30 minute preoperative versus 1 day postoperative administration of ketorolac tromethamine 0.5% ophthalmic solution (Acular) in reducing anterior chamber inflammation after cataract surgery., Setting: The Hermann Eye Center, The University of Texas Health Science Center-Houston, Texas, USA., Methods: Fifty eyes of 48 consecutive patients scheduled for phacoemulsification with intraocular lens implantation were included. Before surgery, patients were randomly assigned to start the study drug 30 minutes preoperatively or 1 day postoperatively. No other antiinflammatory agents were used intraoperatively or postoperatively. Main outcome measures were flare and cell counts., Results: Preoperative and postoperative flare and cell counts did not differ significantly between the 2 treatment groups at any time. Both groups showed significant increases in flare (P =.0001) and cells (P =.0001) 1 day postoperatively. Flare and cells returned to baseline levels by day 28 in both groups. There was no significant difference at any time between the 2 groups in the change from the preoperative level of inflammation., Conclusions: There was no difference between administering ketorolac 30 minutes preoperatively versus 1 day postoperatively in reducing inflammation.

Purpose: To investigate the effects of postoperative atropine on central and peripheral anterior chamber depth and anterior chamber inflammation in patients undergoing primary trabeculectomy., Methods: Two separate groups of patients who were phakic without previous intraocular surgery undergoing primary trabeculectomy were prospectively randomized to atropine or no atropine. In the first group of patients, 24 eyes of 21 patients undergoing primary trabeculectomy were prospectively randomized to atropine or no atropine, and their anterior chamber depth was measured. Central and peripheral chamber depths were measured using the EAS-1000 anterior segment analysis system (Nidek, Tokyo, Japan) before surgery and on postoperative days 1, 3, 7, 14, and 30. In the second group, 34 patients undergoing primary trabeculectomy were prospectively randomized to atropine or no atropine, and their anterior chamber reaction was documented. The amount of cells and flare was measured using the Kowa laser flare meter (FM-500) and cell counter (LC-500) (Kowa Electronics and Optics, Tokyo, Japan) preoperatively and on postoperative day 1, 7, and 30., Results: Compared with preoperative measurements, a small (approximately 0.1 mm) but statistically significant deepening of the central and peripheral anterior chamber depth on days 1, 7, 14, and 30 was found in patients who used atropine. In the nonatropine group, no statistically significant change was found in central or peripheral anterior chamber depths at any time as compared with preoperative values. There was no statistically significant difference in the cell or flare counts between the atropine and nonatropine groups at any time., Conclusions: This study showed a small but statistically significant deepening of the anterior chamber with atropine. No statistically significant differences were observed in the cell or flare counts between atropine and nonatropine groups. Routine atropine use after trabeculectomy may not be necessary to reduce postoperative complications, such as shallowing of the anterior chamber or anterior chamber inflammation. In patients with a shallow anterior chamber, however, atropine would be expected to deepen the chamber.

Objectives: The goal of this study was to compare the outcome of patients with traumatic optic neuropathy (TON) treated with high-dose steroids with the outcome of patients with TON treated with endoscopic optic nerve decompression (EOND) after failing high-dose steroid treatment., Methods: During this retrospective review of patients with TON seen from 1994 to 1998, all patients were first treated with megadose methylprednisolone for 48 hours. Patients with no improvement or with worsening visual acuity were offered EOND., Results: Eleven of 34 (32%) patients treated with high-dose steroids showed improvement, and 23 (68%) did not. Seventeen of the 23 patients without improvement after high-dose steroid treatment underwent EOND. Fourteen of 17 (82%) surgically treated patients had improved visual acuity, and 3 (18%) did not, with an overall improvement in 25 of 34 (74%) patients (chi(2) = 11. 338, P = 0.0007)., Conclusion: EOND is an appropriate treatment technique for patients with TON in whom high-dose steroid treatment has failed.

A 55-yr-old African American man was referred for evaluation of a mass involving the anterior choroid/ciliary body in his left eye. Dilated fundus examination revealed a large, deeply pigmented mass associated with an exudative retinal detachment. Ultrasonography demonstrated an elevated mass which involved the anterior uvea and showed low reflectivity by standardized A-scan. Cytologic examination of fine needle aspiration (FNA) biopsy from the tumor was interpreted as a melanocytoma. The patient developed a total retinal detachment and secondary glaucoma which led to enucleation of the eye. Histopathologic examination confirmed the diagnosis of melanocytoma. To our knowledge, this is the first report in which the diagnosis of uveal melanocytoma was established by FNA biopsy and later confirmed histopathologically., (Copyright 2000 Wiley-Liss, Inc.)

Purpose: Mitomycin C (MMC) is commonly administered during filtering surgery to enhance the success of the procedure. Unfortunately, the increased success rate is associated with complications, including late bleb leaks, endophthalmitis, and ciliary epithelial toxicity. The purpose of this study was to investigate a safe and effective dose regimen for MMC to reduce incidence of those complications., Methods: Trabeculectomy was performed in 36 rabbits. MMC was applied only during surgery, only one day after surgery, or once daily after surgery for 3 days at lower concentrations. Balanced salt solution (BSS) was administered during surgery to one group as a placebo. The time to bleb failure was determined and the eyes were evaluated histopathologically. Success and toxicity were compared for the different treatment groups., Results: The mean time until trabeculectomy failure was 2.83 days for the placebo group, 6.33 days with administration of MMC 0.5 mg/mL during surgery, 7.83 days with administration of MMC 0.5 mg/mL once after surgery, and 11, 9, and 4.83 days with administration of MMC 0.1 mg/mL, 0.05 mg/mL, or 0.025 mg/mL, respectively, once a day for 3 consecutive days. On electron microscopic examination of the ciliary epithelium, toxic effects were greatest with MMC concentrations of 0.5 mg/mL and were less with lower concentrations., Conclusion: The effect of MMC on trabeculectomy survival was dependent on both the concentration and the method of administration. Lower concentrations with multiple postoperative administrations were as effective as but caused less ciliary body toxicity than intraoperative administration of higher concentrations.

Purpose: To determine whether a consensual inflammatory response occurs following unilateral phacoemulsification or trabeculectomy in humans., Methods: Sixty patients undergoing phacoemulsification or primary trabeculectomy were included in the study. Some patients were randomly assigned to have a shield placed on the non-operated eye during surgery. The Kowa laser flare meter (FM-500) and laser cell counter (LC-500) (Kowa Electronics and Optics, Tokyo, Japan) were used to assess the inflammatory response in both eyes. Measurements were taken preoperatively and on postoperative days 1, 7 and 28. The regression analysis with random model effect was used to identify factors which may affect the change of flare and cells in the non-operated eye after surgery. Correlation was evaluated between the inflammatory responses of the paired eyes. A P<0.05 was considered statistically significant for all analyses., Results: The flare and cells in the non-operated eye showed a small, but significant, increase on day 1 (mean flare increased 2.68 photons/ms from preoperative level with P<0.001 and mean cells increased 2.49 cells/0.5 mm3 from preoperative level with P<0.0001). At day 7 the amount of inflammation was still elevated (mean flare increased 0.41 photons/ms from preoperative level with P<0.001 and mean cells increased 0.63 cells/0.5 mm3 from preoperative level with P<0.001). By day 28, the amount of inflammation in the nonoperated eyes returned to preoperative levels., Conclusions: Subclinical inflammation occurs in the non-operated eye following phacoemulsification and trabeculectomy. The etiology of this finding has yet to be elucidated.

Purpose: Management of a case of glaucoma secondary to an iris metastasis is reported., Results: A 31-year-old woman developed glaucoma secondary to a metastatic tumor to the iris. Anti-glaucoma medication failed to control the increase in intraocular pressure (IOP). However, diode laser cyclophotocoagulation controlled the IOP., Conclusion: Glaucoma secondary to an iris metastasis is difficult to manage. Diode laser cyclophotocoagulation is effective in controlling the increase in IOP without affecting visual acuity.

Purpose: To present a patient with the rare condition of lipaemia retinalis and discuss the clinical features of this condition and its association with elevated triglyceride levels., Methods: Clinical evaluation of the patient, including fundus photographs before and after the initiation of a low fat diet, was undertaken., Results: Lowering of serum triglyceride and cholesterol levels was associated with complete resolution of the clinical picture of lipaemia retinalis., Conclusions: Lipaemia retinalis is a rare condition that is related to markedly elevated triglyceride levels. Lowering triglycerides levels leads to resolution of the clinical picture of this disease.

Background and Objective: To compare the efficacy of ketorolac tromethamine 0.5%, diclofenac sodium 0.1%, and prednisolone acetate 1% in reducing flare and cells following cataract surgery., Patients and Methods: Fifty-eight patients undergoing phacoemulsification with posterior chamber intraocular lens implantation were randomly selected to receive either ketorolac tromethamine 0.5%, diclofenac sodium 0.1%, or prednisolone acetate 1% following surgery. The treatment regimen was 1 drop 4 times a day for 1 week, then twice a day for the next 3 weeks. Flare, cells, and intraocular pressures (IOPs) were measured preoperatively and on postoperative days 1, 7, and 28., Results: No statistically significant differences in either actual flare or cell counts or in change in flare or cell counts from baseline were detected among the three groups. No statistically significant differences in IOP or in change of IOP from preoperative measurements were detected. No medication-related complications were noted at any time., Conclusion: Ketorolac tromethamine 0.5% and diclofenac sodium 0.1% may be as effective and as safe as prednisolone acetate 1% in controlling inflammation following cataract extraction.

Background and Objectives: To determine the interobserver and intraobserver reproducibility of the laser flare meter and laser cell counter in assessing anterior chamber inflammation following cataract surgery., Patients and Methods: Thirty-nine eyes with varied degrees of inflammation and 9 normal eyes were included in the study. Anterior chamber flare and cells were evaluated with the slit lamp and graded on a scale of 0 to 4+. The flare and cells were then measured three times each using the flare meter and cell counter by two different, experienced observers. The intraobserver reproducibilities were computed to evaluate repeatability of the instruments operated by the same observer. The first measurement taken by each observer was used to assess reproducibility between the two observers., Results: The intraobserver reproducibility for overall flare was 0.995 for both observers. The intraobserver reproducibility for overall cells was 0.996 for observer 1 and 0.991 for observer 2. The overall interobserver reproducibility was 0.994 for flare and 0.988 for cells. The correlation between measurements and slit-lamp ratings was 0.78 for flare and 0.56 for cells., Conclusions: The intraobserver and interobserver reproducibilities were excellent, with good correlation to slit-lamp measurements. Reproducible results can be obtained using the laser flare meter and the laser cell counter. It is not known whether these results are applicable to other inflammatory processes with higher grades of flare and cells and with different protein and cell types.

We examined a 73-year-old woman with bilateral malignant melanoma of the choroid associated with multiple nonocular malignancies. Fine-needle aspiration biopsy was performed in the left eye to provide a tissue diagnosis. Cytologic examination of the lesion in the left eye confirmed the diagnosis of primary malignant choroidal melanoma. This case demonstrates that bilateral malignant melanoma of the choroid occurs more frequently than expected, and may be associated with nonocular malignancies.

Purpose: The purpose of this study was to describe a possible mechanism of failure of the Ahmed glaucoma valve (AGV; New World Medical, Rancho Cucamonga, CA)., Method: Two AGVS that failed to control intraocular pressure (IOP) were examined. In vivo examination consisted of unroofing the capsule surrounding the implant and injecting fluorescein-stained balanced salt solution into the tube. In one case the entire implant was removed and examined in vitro, and in the other case only the valve portion was removed., Result: No flow in either case extended beyond the valve. In both cases, the membrane valve system was found to be fused and could not be pulled apart., Conclusion: Failure of the AGV may occur due to adhesion of the valve membranes.