Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device.

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.

Clinical evaluation of a bacterially derived sodium hyaluronate 2.3% ophthalmic viscosurgical device.

PURPOSE: To compare the safety and effectiveness of bacterially derived and animal-derived sodium hyaluronate 2.3% ophthalmic viscosurgical devices (OVD) (Healon5 PRO and Healon5, respectively) in cataract surgery. SETTING: United States multicenter study. DESIGN: Prospective, randomized, masked, controlled study. METHODS: Adult patients having bilateral cataract extraction and posterior chamber intraocular lens implantation were randomly assigned to receive Healon5 PRO OVD in 1 eye (study group) and Healon5 OVD in the fellow eye (control group). The endothelial cell count (ECC) was measured preoperatively and 3 months postoperatively. Tonometry was performed preoperatively and at the 6-hour, 1-day, 1-week, 1-month, and 3-month timepoints. The cumulative rate of postoperative intraocular pressure (IOP) spikes (≥30 mm Hg) was calculated. Changes from baseline in IOP, edema, inflammation, serious adverse events, and visual acuity were also assessed. RESULTS: The study comprised 213 and 208 treated and paired-eye patients, respectively. At 3 months, there was no statistically significant difference in the mean percentage ECC change from baseline between study group and the control group (-5.55% versus -6.66%; mean difference 1.11% ± 11.89% [SD]; 95% confidence interval (CI), -0.52 to 2.74) or the cumulative IOP spike rate (8.2% versus 6.3%; mean percentage difference -1.9%; 95% CI, -5.46% to 1.61%). At 3 months, both OVD groups had significant reductions in IOP from baseline (-1.37 mm Hg and -1.32 mm Hg, respectively; both P < .0001). The distribution of edema, inflammation, serious adverse events, and visual acuity outcomes was also similar between the groups. CONCLUSION: The 2 OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification.

BACKGROUND: The 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. METHODS: Four 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. RESULTS: OMS302 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. CONCLUSION: OMS302 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.

Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants.

PURPOSE: To compare the visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens (IOLs) implants. DESIGN: Prospective, nonrandomized study. METHODS: Forty-nine patients were implanted with bilateral Crystalens (Eyeonics, Aliso Viejo, California, USA), ReSTOR (Alcon Laboratories, Fort Worth, Texas, USA), and ReZoom (American Medical Optics, Santa Clara, California, USA) or combined Crystalens and ReSTOR or Crystalens and ReZoom IOLs after phacoemulsification. Monocular and binocular testing four to six months after surgery included uncorrected and best-spectacle corrected visual acuity at distance, intermediate, and near vision; mesopic contrast sensitivity function with and without glare; and quality-of-life and vision surveys six months after surgery. RESULTS: Monocular testing showed that eyes with Crystalens accommodating IOL had statistically better best-spectacle corrected distance, uncorrected and distance-corrected intermediate, and best-corrected near vision. Eyes with the ReSTOR multifocal IOL had better uncorrected near vision, required the lowest reading add, and had the lowest uncorrected and distance-corrected intermediate vision. Monocular mesopic contrast sensitivity with and without glare was better with the Crystalens IOL vs either multifocal IOL at specific spatial frequencies. The binocular subjective quality of vision and quality of life questionnaires were favorable for the bilateral Crystalens group. CONCLUSIONS: Any combination of Crystalens in one or both eyes was better for intermediate vision. Any combination of ReSTOR in one or both eyes was better for near vision. The Crystalens and ReSTOR combination had better mean intermediate and near vision overall. A multifocal IOL in one or both eyes was associated with lower contrast sensitivity and more subjective reports of photic phenomena. The accommodating and multifocal IOL combinations elicited less night glare symptoms than in patients with either bilateral multifocal IOL, but more than with bilateral Crystalens implantation.