Prednisolone and Ketorolac vs Ketorolac Monotherapy or Sub-Tenon Prophylaxis for Macular Thickening in Cataract Surgery: A Randomized Clinical Trial.

IMPORTANCE: The choice of anti-inflammatory prophylaxis parallel to cataract surgery is important for patient safety and successful outcome of surgery, but which regimen to choose is contested. OBJECTIVES: To determine whether a combination of prednisolone and nonsteroidal anti-inflammatory drug (NSAID) eye drops was superior in preventing increased central macular thickness (central subfield thickness [CST]) after uncomplicated cataract surgery compared with NSAID monotherapy and sub-Tenon capsule depot (dropless surgery), and to test whether preoperative initiation of eye drop treatment was superior to initiation on the day of surgery. DESIGN, SETTING, AND PARTICIPANTS: This investigator-driven, single-center, randomized clinical trial with masked statistical analyses enrolled patients at the Department of Ophthalmology, Rigshospitalet Glostrup, Glostrup, Denmark, from February 1, 2018, to August 15, 2019. Follow-up was completed December 18, 2019. Participants included low-risk patients undergoing phacoemulsification for age-related cataract by an experienced surgeon (1 eye per participant). Data were analyzed from February 17 to June 15, 2020. INTERVENTIONS: Participants scheduled for cataract removal were randomized to 1 of 5 anti-inflammatory prophylactic regimens: eye drops with a combination of prednisolone, 1%, and ketorolac tromethamine, 0.5%, with or without preoperative initiation (preoperative prednisolone plus NSAID [control] and postoperative prednisolone plus NSAID groups), ketorolac monotherapy with or without preoperative initiation (preoperative and postoperative NSAID groups), or sub-Tenon depot of dexamethasone phosphate (sub-Tenon group). Eye drops were administered 3 times per day until 3 weeks postoperatively. MAIN OUTCOMES AND MEASURES: CST 3 months postoperatively. RESULTS: A total of 470 participants (mean [SD] age, 72.2 [7.0] years; 290 women [61.7%]) with 94 participants in each group were included in the analysis. Three months after surgery, the mean CST was 250.7 (95% CI, 247.6-253.7) µm in the preoperative prednisolone plus NSAID group, 250.7 (95% CI, 247.8-253.7) µm in the postoperative prednisolone plus NSAID group, 251.3 (95% CI, 248.2-254.4) µm in the preoperative NSAID group, 249.2 (95% CI, 246.2-252.3) µm in the postoperative NSAID group, and 255.2 (95% CI, 252.0-258.3) µm in the sub-Tenon group. There were no significant differences in CST or visual acuity compared with control and no differences between preoperative and postoperative groups, but 47 of 83 participants (56.6%) in the sub-Tenon group needed additional anti-inflammatory treatment. CONCLUSIONS AND RELEVANCE: No differences in CST or visual acuity were detected between the combination of prednisolone and NSAID eye drops vs NSAID monotherapy or sub-Tenon dexamethasone depot, although more than one-half of patients in the sub-Tenon arm received additional anti-inflammatory treatment. Initiating prophylaxis 3 days preoperatively was not superior to initiation on the day of surgery. Monotherapy with NSAIDs may be preferred in uncomplicated cataract surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03383328.

Simulation of advanced cataract surgery - validation of a newly developed test.

PURPOSE: To develop and investigate an Eyesi simulator-based test for the more experienced cataract surgeon for evidence of validity. METHODS: The study was a prospective interventional cohort study and carried out at the Copenhagen Academy for Medical Education and Simulation. The Eyesi Simulator was used for the test which was developed by three expert cataract surgeons. Ten cataract surgeons (>250 surgeries performed) and ten ophthalmic residents performed two repetitions of the test. The test consisted of four modules: Iris Expansion Ring insertion - level 1, Iris Expansion Ring extraction - level 2, Capsulorhexis - level 3 and Anterior Vitrectomy - level 6. RESULTS: Internal consistency reliability showed Cronbach's alpha of 0.63. Test-retest reliabilities were significant for Iris Expansion Ring extraction - level 2 (p = 0.012) and Capsulorhexis - level 3 (p = 0.018). Differences between the two groups were only significant in both repetitions for the Iris Expansion Ring extraction - level 2 (p < 0.001 and p = 0.041, respectively). Furthermore, we found a statistically significant difference between the mean module scores for novices and the more experienced surgeons for Iris Expansion Ring insertion - level 1 (p = 0.021) and Capsulorhexis - level 3 (p = 0.019) in the first repetition. CONCLUSION: The investigated modules show evidence of validity within several aspects of Messick's framework. However, the evidence is not strong enough to apply the test for certification purposes of cataract surgeons, but the modules may still be relevant in the training of advanced cataract surgical procedures.

ROBOT-ASSISTED VITREORETINAL SURGERY IMPROVES SURGICAL ACCURACY COMPARED WITH MANUAL SURGERY: A Randomized Trial in a Simulated Setting.

PURPOSE: To compare manual and robot-assisted vitreoretinal surgery using a virtual-reality surgical simulator. METHODS: Randomized controlled crossover study. Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons were included. The participants were randomized to start with either manual or robot-assisted surgery. Participants completed a test session consisting of three vitreoretinal modules on the Eyesi virtual-reality simulator. The automated metrics of performance supplied by the Eyesi simulator were used as outcome measures. Primary outcome measures were time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm). RESULTS: Robot-assisted surgery was slower than manual surgery for both novices and vitreoretinal surgeons, 0.24 SD units (P = 0.024) and 0.73 SD units (P < 0.001), respectively. Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively. Finally, novices using robot-assisted surgery inflicted less tissue damage when compared with that using manual surgery, -0.59 SD units (P = 0.009). CONCLUSION: At the cost of time, robot-assisted vitreoretinal surgery seems to improve precision and limit tissue damage compared with that of manual surgery. In particular, the performance of novice surgeons is enhanced with robot-assisted vitreoretinal surgery.