Effects of clinical parameters on patient-reported outcome in cataract patients: a multicentre study.

PURPOSE: Ophthalmologists tend to evaluate the results of cataract surgery by focusing on the clinical visual and refractive outcomes and the incidence of complications, where patients' main interest might be their ability to perform daily activities. Therefore, there appears to be a need for optimizing effective communication between patients and ophthalmologist about the outcome of cataract surgery. The aim of this multicentre study was to determine the effects of whether the surgery was performed in one or two eyes, ocular comorbidity and per- and postoperative complications on visual function experienced by patients measured with the Catquest-9SF. METHODS: To measure patient-reported outcomes, Catquest-9SF data were collected between 2014 and 2015 in five Dutch hospitals. Data from 870 pairs of questionnaires - completed before and after cataract surgery - were compared with clinical data. Clinical data, retrieved from patients' medical files, consisted of one or two eye surgery, ocular comorbidity and per- and postoperative complications. RESULTS: Quality of vision improved more in patients who had surgery in both eyes and had fewer postoperative complications (both p < 0.001). We found a nonsignificant trend that quality of vision was worse when ocular comorbidity was present. No significant effect of peroperative complications was observed. CONCLUSION: Our results emphasize the added value of the Catquest-9SF as a tool for visual function experienced by patients; the additional information can complement clinical parameters to improve patient-centred approaches in clinical practice.

In vitro delivery performance assessment of a new preloaded intraocular lens delivery system.

PURPOSE: To compare the delivery performance of a new preloaded intraocular lens (IOL) delivery system (Ultrasert [system U]) with that of 2 commercially available preloaded systems (iSert [system S] and Tecnis iTec [system T]), and a manual system (Monarch III D). SETTING: Alcon Laboratories, Fort Worth, Texas, USA. DESIGN: Experimental study. METHODS: Freshly excised porcine eyes were randomly assigned to 5 groups of 10 eyes each as follows: preloaded systems U, S, T 2.2 mm incision, T 2.4 mm incision, and manual system. Corneal incision size was measured before and after delivery. The rate of successful in-the-bag IOL delivery, IOL adherence to the plunger tip, trapped trailing haptic, and presence of nozzle tip splitting were assessed. Statistical analysis was performed to determine the significance of differences between groups. RESULTS: All systems successfully placed the IOL in the capsular bag. System U had the least corneal incision enlargement (mean 0.07 mm ± 0.05 [SD]) and the smallest final incision size (mean 2.31 ± 0.06 mm) (P < .05). An associated split in the nozzle tip was observed for system S devices (P < .05). Furthermore, in more than 50% of deliveries with system T, the IOL remained adhered to the plunger tip after exiting the nozzle (P < .05). Systems S and T each had 1 occurrence of a trapped trailing haptic during IOL delivery. CONCLUSION: The new design of the system U with a depth-guard nozzle tip allowed for the smallest incision enlargement with an absence of nozzle tip splitting and uneventful IOL delivery compared with the other preloaded systems tested in this study. FINANCIAL DISCLOSURE: Drs. Tjia and Lane are consultants to Alcon Laboratories, Inc. Drs. Wang, Wolfe, Paliwal, and Miss Chernosky are employees of Alcon Laboratories, Inc.

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.

Intraocular straylight after implantation of the multifocal AcrySof ReSTOR SA60D3 diffractive intraocular lens.

PURPOSE: To measure intraocular straylight (as a measure of glare) after cataract surgery and implantation of an AcrySof ReSTOR SA60D3 multifocal or AcrySof SA60AT monofocal intraocular lens (IOL) (both Alcon Laboratories). SETTING: University Hospital Maastricht, Maastricht; Isala Clinics, Zwolle; Netherlands Institute for Neurosciences, Amsterdam, The Netherlands. METHODS: In a prospective open observational case series, a newly developed straylight meter was used to objectively measure straylight 6 months postoperatively in 66 eyes with a diffractive AcrySof ReSTOR SA60D3 IOL (multifocal group) and 40 eyes with a monofocal AcrySof SA60AT IOL (monofocal group). A comparison of straylight levels in an age-matched population without cataract (control group) was performed. RESULTS: The straylight level was 1.20 log units +/- 0.16 (SD) in the multifocal group and 1.10 +/- 0.19 log units in the monofocal group. When the difference in mean level of straylight was adjusted for age, mean straylight levels were 0.078 log units lower in the monofocal group than in the multifocal group (P = .026). Straylight levels in both pseudophakic groups were lower than in the control group without cataract (P< .0001). CONCLUSIONS: Levels of intraocular straylight log(s) were significantly lower for both types of IOL than in age-matched subjects from the normal population. The mean level of intraocular straylight 6 months postoperatively was higher in patients with an AcrySof ReSTOR SA60D3 IOL than in patients with a monofocal AcrySof SA60AT IOL. Implantation of the former IOL would therefore result in a smaller gain in contrast sensitivity and a smaller reduction in glare and halos than implantation of the latter IOL.

Posterior capsule opacification: silicone plate-haptic versus AcrySof intraocular lenses.

PURPOSE: To evaluate posterior capsule opacification (PCO) in fellow eyes, 1 receiving a silicone intraocular lens (IOL) and the other, an acrylate IOL. SETTING: Department of Ophthalmology, Isala Clinics, Zwolle, The Netherlands. METHODS: This retrospective study comprised 107 patients (214 eyes). In each patient, 1 eye was randomly selected to have implantation of an acrylate IOL (AcrySof MA30BA or MA60BM, Alcon) and the other eye, a plate-haptic silicone IOL (AA4203VF, Staar). Outcome measures were the total PCO index, percentage of neodymium:YAG (Nd:YAG) capsulotomies performed, and logMAR best corrected visual acuity (BCVA). The follow-up was 3 years. RESULTS: The total PCO index was significantly lower in the AcrySof group than in the plate-haptic silicone group (P<.0001). There was no significant difference in logMAR BCVA between groups (P>.05). The percentage of Nd:YAG laser treatments was significantly lower in the AcrySof group (2.8%) than in the plate-haptic silicone group (23.1%) (P<.05). CONCLUSIONS: There was significantly less PCO and a lower Nd:YAG laser capsulotomy rate after AcrySof IOL implantation than after plate-haptic silicone IOL implantation. These results did not seem to affect the logMAR BCVA as there were no significant differences between groups in this parameter.