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Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.

ABSTRACT: Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual outcomes through greater precision and reproducibility, and improved safety. FACT is a randomised single masked non-inferiority trial to establish whether laser-assisted cataract surgery is as good as or better than standard manual phacoemulsification.808 patients aged 18?years and over with visually significant cataract will be randomised to manual phacoemulsification cataract surgery (standard care) or laser-assisted cataract surgery (intervention arm). Outcomes will be measured at 3 and 12?months after surgery. The primary clinical outcome is uncorrected distance visual acuity (UDVA, logMAR) at 3?months in the study eye recorded by an observer masked to the trial group. Secondary outcomes include UDVA at 12?months, corrected distance visual acuity at 3 and 12?months, complications, endothelial cell loss, patient-reported outcome measures and a health economic analysis conforming to National Institute for Health and Care Excellence standards.Research Ethics Committee Approval was obtained on 6 February 2015, ref: 14/LO/1937. Current protocol: v2.0 (08/04/2015). Study findings will be published in peer-reviewed journals.77602616.

SUBMITTER: Day AC

PROVIDER: S-EPMC4663449 | biostudies-other | 2015 Nov

REPOSITORIES: biostudies-other

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Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.

Day Alexander C AC Burr Jennifer M JM Bunce Catey C Doré Caroline J CJ Sylvestre Yvonne Y Wormald Richard P L RP Round Jeff J McCudden Victoria V Rubin Gary G Wilkins Mark R MR

BMJ open 20151127 11

<h4>Introduction</h4>Cataract is one of the leading causes of low vision in the westernised world, and cataract surgery is one of the most commonly performed operations. Laser platforms for cataract surgery are now available, the anticipated advantages of which are broad and may include better visual outcomes through greater precision and reproducibility, and improved safety. FACT is a randomised single masked non-inferiority trial to establish whether laser-assisted cataract surgery is as good ...[more]

PMID: 26614627

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Project description:PurposeTo 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).DesignMulticenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).ParticipantsSeven hundred eighty-five patients with age-related cataract.MethodsThis 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 measuresWe 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.ConclusionsFemtosecond 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.

Project description:Purpose: To compare 1-year clinical outcomes, phacoemulsification energy, aqueous profiles, and patient-reported outcomes of low-energy femtosecond laser-assisted cataract surgery (FLACS) vs. conventional phacoemulsification. Methods: The study is a randomized controlled trial (RCT) with paired-eye design. Eighty-five patients were randomized to receive FLACS (Ziemer LDV Z8) in one eye and conventional phacoemulsification in the fellow eye. Clinical data including phacoemulsification energy parameters (cumulative dissipated energy, phacoemulsification power, and phacoemulsification time), uncorrected and corrected distance visual acuities (UCDVA and BCDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness (CCT), endothelial cell count (ECC), anterior chamber flare, and post-operative complications were obtained for 1 year. Aqueous humor was collected for the analysis of prostaglandin (PGE)2, cytokines and chemokines concentrations. Patients' reported-outcomes on surgical experiences were evaluated using an in-house questionnaire. Results: Compared to conventional phacoemulsification, the low-energy assisted FLACS group had significantly less ECC reduction at 3 months (1.5 ± 0.3% vs. 7.0 ± 2.4%; P < 0.01) and 1 year (8.2 ± 2.8% vs. 11.2 ± 3.6%; P = 0.03). There were no significant differences in the phacoemulsification energy parameters, UCDVA, BCDVA, MRSE, CCT, occurrence of post-operative complications between the 2 groups throughout post-operative 1 year. Patients' subjective surgical experiences, including the surgical duration and perceived inconvenience, were comparable between the 2 groups. FLACS resulted in significantly higher aqueous PGE2 (P < 0.01), interleukin (IL)-6 (P = 0.03), IL-8 (P = 0.03), and interferon (IFN)-γ (P = 0.04) concentrations and greater anterior chamber flare at 1 day (P = 0.02). Conclusions: Our RCT presented 1-year longitudinal clinical and laboratory data. The long-term ECC result was more favorable in low-energy FLACS. The rest of the intraoperative and post-operative outcomes, as well as patient-reported outcomes, were comparable between these two procedures.

Project description:OBJECTIVES:To investigate differences in surgical time, the distance the surgical instrument travelled and number of movements required to complete manual phacoemulsification cataract surgery versus femtosecond laser cataract surgery. DESIGN:Non-randomised comparative case series. SETTING:Single surgery site, Moorfields Eye Hospital, UK. PARTICIPANTS:40 cataract surgeries of 40 patients. INTERVENTIONS:Laser-assisted and manual phacoemulsification cataract surgery. Laser-assisted surgery cases were performed using the AMO Catalys platform. PRIMARY AND SECONDARY OUTCOME MEASURES:Computer vision tracking software PhacoTracking were applied to the recordings to establish the distance the instrument travelled, total number of movements (the number of times an instrument stops and starts moving) and time taken for surgery steps including phacoemulsification, irrigation-aspiration (IA) and overall surgery time. The time taken for laser docking and delivery was not included in the analyses. RESULTS:Data on 19 laser-assisted and 19 manual phacoemulsification surgeries were analysed (two cases were excluded due to insufficient video-recording quality). There were no differences in the number of instrument moves, the distance the instrument travelled or time taken to complete the phacoemulsification stage. However for IA, the number of instrument moves (manual: mean 20 (SD 15) vs laser: mean 38 (SD 22), P=0.008) and time taken (manual: mean 75?s (SD 24) vs laser: mean 108?s (SD 36), P=0.003) were significantly greater for laser cases. For laser versus manual cases overall, there was no difference in number of moves or the distance the instrument travelled, but laser cases took longer (mean 88?s, P=0.049). CONCLUSIONS:Laser cataract surgery cases took longer to complete without accounting for the time taken to complete the laser procedure itself. This appears to be in part due to IA requiring more instrument manoeuvres and taking longer to complete. Data from a large randomised series would better elucidate this relationship.

Project description:BackgroundOptical quality and macular thickness changing optical quality is rarely reported after femtosecond laser-assisted cataract surgery (FLACS). In current research, we evaluated optical quality recovery and distinct macular thickness changes after FLACS and phacoemulsification cataract surgery (PCS).MethodsA total of 100 cataract patients (100 eyes) were included (50 eyes for the FLACS group and 50 eyes for the PCS group). Modulation transfer function (MTF), point spread function (PSF) and dysfunctional lens index (DLI) were measured by a ray-tracing aberrometer (iTrace). Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were also assessed pre-operation,1?week and 1?month after surgery. The MTF values at spatial frequencies of 5, 10, 15, 20, 25 and 30?cycles/degree (c/d) were selected. We used optical coherence tomography (OCT) to assess the macular thickness of different regions pre-operatively and1month after the surgery.ResultsIn PCS group, we found the statistically significant differences between pre-operation and post-operation in DLI (p?<?0.0001), PSF (strehl ratio, SR) (p?= 0.027) and MTF (p?=?0.028), but not intraocular pressure (IOP) (p?=?0.857). The differences between pre-operation and post-operation for DLI (p?=?0.031), SR (p?=?0.01) and IOP (p?=?0.03), but not MTF (p?=?0.128) were also found in FLACS group. The differences were statistically significant when the spatial frequencies were at 5, 10 and 25 (p?=?0.013, 0.031 and 0.048) between pre-operation and post-operation in PCS group but not FLACS group at 1?month. In PCS group, we found the differences between pre-operation and post-operation in nasal inter macular ring thickness (NIMRT) (p?=?0.03), foveal volume (FV) (p?=?0.034) and average retinal thickness (ART) (p?=?0.025) but not FLACS group at 1?month.ConclusionFLACS is safe that did not cause significant increase of macular thickness in current study. However, it also cannot produce better optical quality. In contrast, PCS can produce macular thickness changes, but better optical quality recovery. The slightly retinal change may not affect optical quality.

Project description:Introduction During femtosecond laser-assisted cataract surgery (FLACS), there is a significant increase in intraocular pressure, which might lead to ganglion cell damage. We aimed to determine whether there were differences in the changes produced in the ganglion cell complex (GCC) and peripapillary retinal nerve fiber layer (pRNFL) thickness, as evaluated with optical coherence tomography (OCT), between phacoemulsification and FLACS, after implantation of a trifocal intraocular lens (IOL). Methods Patients with no coexistent pathologies undergoing cataract surgery with implantation of a PanOptix IOL were explored with the Cirrus-OCT before and three months after surgery. GCC values were obtained from the built-in software. The differences between pre- and postoperative GCC and pRNFL thicknesses after phacoemulsification were compared to differences after FLACS. Results A total of 171 eyes were included, 74 undergoing FLACS and 97 phacoemulsification. For both groups, there was a statistically significant increase in GCC values after cataract surgery, except for the inferior and inferonasal sectors. There were no statistically significant differences between FLACS and phacoemulsification. Mean change in average GCC and minimum GCC were 1.08?±?1.40?µm (range ?1 to +6?µm) and 1.69?±?2.54?µm (range ?3 to +11?µm) after FLACS and 0.99?±?1.67?µm (range ?5 to +6?µm) and 2.02?±?3.54?µm (?6 to +18?µm) after phacoemulsification. These values are similar to those previously reported after phacoemulsification with monofocal IOL implantation. No significant changes after surgery were detected for the pRNFL, with no differences between groups. Discussion. There were no differences in the changes produced by FLACS and phacoemulsification in either GCC or pRNFL values. Although mean change was small, the range of variation was wide. Therefore, it is necessary to establish a new baseline for GCC and pRNFL thicknesses after cataract surgery in order to monitor any subsequent changes.

Dataset Information

Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.

Publications

Randomised, single-masked non-inferiority trial of femtosecond laser-assisted versus manual phacoemulsification cataract surgery for adults with visually significant cataract: the FACT trial protocol.

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