Jugoslavenska mornarica u završnim operacijama ,,Jadranu sloboda"

The trial was funded by the National Institute of Health Research (NIHR) Health Technology Assessment Panel (project reference number HTA 13/04/46 and was sponsored by University College London (UCL).Purpose To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS). Design Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/). Participants Seven hundred eighty-five patients with age-related cataract. Methods This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616. Main Outcome Measures We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome. Conclusions Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.Publisher PDFPeer reviewe

Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery (FACT): a randomised non-inferiority trial, 1 year outcomes

PURPOSE: To report the 1 year outcomes of a randomised trial comparing femtosecond laser assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS). SETTING: Moorfields Eye Hospital, New Cross Hospital and Sussex Eye Hospital, UK DESIGN:: Multicentre, randomised controlled non inferiority trial. METHODS: 311 of 392 (79%) participants allocated to FLACS and 292 of 393 (74%) participants allocated to PCS attended follow-up at 1 year. Postoperative assessments were masked to the allocated intervention. Outcomes included UDVA, CDVA, complications, corneal endothelial cell count and patient reported outcomes measures. ISRCTN77602616. RESULTS: Mean UDVA was 0.14 (SD 0.22) for FLACS and 0.17 (0.25) for PCS with difference between treatment arms of -0.03 logMAR (95% CI: -0.06 to 0.01, p=0.17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI -0.06 to 0.01, p=0.11). 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5D refractive target, and 95% FLACS (292/307) and 96% PCS (279/290) cases within ±1.0D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (p=0.036) favouring FLACS. The mean cost difference was £167.62 per patient greater for FLACS (95% of iterations between -£14.12 and £341.67). CONCLUSIONS: PCS is not inferior to FLACS in terms of vision, patient reported health and safety outcomes after one year follow-up. A difference was found for binocular CDVA, which whilst statistically significant, was not clinically important. FLACS is not cost effective