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BackgroundThe purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery.MethodsFour hundred and six patients (406 study eyes; 202 in the OMS302 group and 204 in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15 centers in the USA and the Netherlands. The patients received OMS302 (60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12 hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain.ResultsOMS302 was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302 – placebo) in change in the area under the curve from baseline for pupil diameter was 0.590 ([0.049]; 95% confidence interval 0.494 to 0.686; P<0.0001). For ocular pain scores, the weighted mean (standard error) difference was −4.580 ([1.192]; 95% confidence interval −6.917 to 2.244; P=0.0002). All secondary efficacy results favored OMS302. Specifically, analyses supporting prevention of miosis (patients with ≥6 mm pupil diameter at completion of cortical clean-up and those with <6 mm diameter at any time during surgery) were significant for OMS302 (95.9% versus 77.0% and 9.2% versus 38.0%, respectively; P<0.0001 for each endpoint). OMS302 was well tolerated and not associated with any unexpected adverse events.ConclusionOMS302 maintained mydriasis, prevented miosis, and reduced early postoperative pain when administered in irrigation solution during intraocular lens replacement, with a safety profile similar to that of placebo. OMS302 is preservative-free and bisulfite-free, and its administration does not require any modification to the surgical procedure.

Intraoperative positive pressure with resulting iris and lens prolapse can pose a difficult scenario during penetrating keratoplasty. In the Price graft-over-host technique, the graft is sutured across the trephinated host cornea, which maintains a formed anterior chamber and thus avoids intraoperative complications. The technique was used in 33 eyes, and no primary or secondary graft failures occurred. Eleven episodes of acute rejection in 11 eyes were treated successfully with steroids.

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Purpose: To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. Setting: 22 sites in the United States. Design: Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). Methods: Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. Results: 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). Conclusions: The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.

Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical deviceWe have read with great interest the article by Packer et al. and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.First, there is a discussion of how a surgeon's technique and preferences influence their selection of an ophthalmic viscosurgical device (OVD) and further that this selection may affect the surgery success, postoperative outcome, and patient satisfaction. Then later in the Discussion section, it is noted that the surgeons were only permitted to use a cohesive OVD. We believe this presents a potentially confounding variable. That is, a surgeon's familiarity with cohesive OVDs, without being randomized across groups, could have potentially skewed the data on postoperative outcomes.In addition, the authors report that 77.7% of the patients were White and that 62% were women. This confounding demographic selection could have affected the outcomes of the treatments. According to other studies, there is a potential relationship between race or sex and cataract or refractive surgery outcomes. Two such studies found that women consistently had poorer outcomes and were less satisfied with their vision. 2,3 Another study found that people of different ethnicities had statistically significant variations in the dimensions and position of their lens and capsular bag. 4 As such, the generalizability of the results of Packer et al. could potentially be decreased.Finally, in the "Surgical Procedure and Follow-up" subsection, the authors state that only 1 eye from each patient was used in the study. However, it is not stated how each eye was chosen on each patient and whether the patients had 1 or both eyes operated on using the StableVisc cohesive OVD. This brings into question the internal validity of findings, although this may have just been a mistaken omission.Overall, we applaud the researchers for their interesting new study on a brand new surgical tool. We look forward to seeing this future publication and the effect it could have for the development of new and improved surgical technology and medicine. We believe that with some of these potentially confounding variables addressed, this study could provide great benefit to physicians and their patients. Further highquality studies should be conducted exploring this potentially beneficial cohesive OVD medical tool to further that goal.

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