Perioperative time and economic impact of an intracameral combination of mydriatics and anaesthetics in routine cataract surgery.

PURPOSE: The aim of this study was to compare the perioperative time and economic impact of a licensed intracameral anaesthetic/mydriatic combination (Mydrane) during routine cataract surgery. METHODS: A real-life, prospective, comparative study was performed in 3 clinical centres in France. Preoperative, surgical, and post-operative times were determined for two mydriasis strategies using conventional preoperative mydriatics/anaesthetics eye drops (control regimen) or Mydrane administered at time of surgery. Staff, surgery schedules and drugs utilisation were collected over 12 surgery half-days. The total cost of each strategy was estimated based on treatment cost and nursing costs. RESULTS: The analysis included 112 routine cataract surgeries (57 surgeries using Mydrane and 55 using the topical regimen) without protocol deviations or complicated surgery. Overall, the mean time between administration of the first mydriatic eye drops or Mydrane and the end of the surgery was 27.4 ± 21.1 min in the Mydrane group vs. 90.3 ± 30.4 min in the control group (P < 0.0001). The total time of the procedure (from admission to discharge) was not significantly different between groups (P = 0.1611). On average, the extra cost of drugs per patient in the Mydrane group (€5.81) was almost balanced by the reduced nursing time (€5.57) with some variations between centres, due to different organisation including staff resource and consumable. CONCLUSIONS: The Mydrane strategy produced perioperative nursing time saving and cost reduction provided that adaptation and reorganisation of routine cataract surgery are implemented.

Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system.

PURPOSE: To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System). SETTING: Six study sites (four in Spain and two in France). DESIGN: Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. MATERIALS AND METHODS: Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit. RESULTS: One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]). CONCLUSION: Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system.

Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery.

PURPOSE: To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery. SETTING: European multicenter study. DESIGN: Prospective randomized controlled study. METHODS: Patients with cataract had phacoemulsification and intraocular lens implantation in 1 eye. They were randomly assigned to receive OVD 1 or OVD 2. Preoperative and postoperative examinations over 3 months included mean intraocular pressure (IOP), incidence of IOP peaks (≥30 mm Hg and ≥24 mm Hg), endothelial cell count (ECC), corneal thickness, and intraocular inflammation. A subjective evaluation of the OVDs was performed. RESULTS: The study comprised 220 patients. The incidence of IOP peaks and the mean IOP were not statistically significantly different between the 2 groups at any of the follow-up visits. At 6 hours, the incidence of IOP spikes 30 mm Hg or higher was 6.5% and 7.2% in the OVD 1 and the OVD 2 groups, respectively (P = .846). For the IOP spikes 24 mm Hg or higher, the incidence was 16.8% and 25.2%, respectively (P = .128). Three months postoperatively there was no statistically significant difference in ECC and pachymetry between the 2 groups. Mild inflammation was noticed up to 7 days postoperatively after which it resolved in both groups. Subjectively, the OVD 2 was easier to use, whereas the OVD 1 had better cohesive and dispersive properties. CONCLUSIONS: Both OVDs have similar performance and safety profiles in phacoemulsification cataract surgery. No clinically relevant differences were found between the 2 devices regarding transient IOP spikes, mean IOP, corneal endothelium injury, or inflammation.