Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT

BACKGROUND: Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps. OBJECTIVES: To compare FLACS with phacoemulsification cataract surgery (PCS). DESIGN: Multicentre, outcome-masked, randomised controlled non-inferiority trial. SETTING: Three collaborating NHS hospitals. PARTICIPANTS: A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017. INTERVENTION: FLACS (n = 392 participants) or PCS (n = 393 participants). MAIN OUTCOME MEASURES: The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention. RESULTS: A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of -0.01 logMAR (95% confidence interval -0.05 to 0.03 logMAR; p = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (-0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS; p = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR; p = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR; p = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR (95% confidence interval -0.05 to 0.00 logMAR) (p = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between -£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between -0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620. LIMITATIONS: Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked. CONCLUSIONS: The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months' follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months' follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective. FUTURE WORK: To explore the possible differences in vision in patients without ocular co-pathology. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77602616. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used)

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial

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

Growth factor restriction impedes progression of wound healing following cataract surgery: identification of VEGF as a putative therapeutic target

Secondary visual loss occurs in millions of patients due to a wound-healing response, known as posterior capsule opacification (PCO), following cataract surgery. An intraocular lens (IOL) is implanted into residual lens tissue, known as the capsular bag, following cataract removal. Standard IOLs allow the anterior and posterior capsules to become physically connected. This places pressure on the IOL and improves contact with the underlying posterior capsule. New open bag IOL designs separate the anterior capsule and posterior capsules and further reduce PCO incidence. It is hypothesised that this results from reduced cytokine availability due to greater irrigation of the bag. We therefore explored the role of growth factor restriction on PCO using human lens cell and tissue culture models. We demonstrate that cytokine dilution, by increasing medium volume, significantly reduced cell coverage in both closed and open capsular bag models. This coincided with reduced cell density and myofibroblast formation. A screen of 27 cytokines identified nine candidates whose expression profile correlated with growth. In particular, VEGF was found to regulate cell survival, growth and myofibroblast formation. VEGF provides a therapeutic target to further manage PCO development and will yield best results when used in conjunction with open bag IOL designs

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

Mini-incision cataract surgery and toric lens implantation for the reduction of high myopic astigmatism in patients with pellucid marginal degeneration

Purpose: To evaluate the clinical outcomes, safety, and efficacy of cataract surgery with the implantation of a toric intraocular lens (IOL) in eyes with stable pellucid marginal degeneration (PMD). Methods: Eleven eyes (eight patients) diagnosed as stable PMD and cataract underwent mini-incision 2.2 mm cataract surgery followed by the implantation of hydrophobic toric aspheric IOL (AcrySof IQ Toric IOL, Alcon, Fort Worth, TX, USA). Perioperative variables of interest included uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, and corneal topography. Paired samples t-tests were used to analyze preoperative and postoperative visual acuity, astigmatism, and spherical equivalent (SE) parameters. Follow-up was 6 months. Results: The mean CDVA was 0.62±0.26 logMAR preoperatively and 0.07±0.07 logMAR postoperatively. The mean preoperative sphere and cylinder was -3.14±3.58D and -4.84±2.02D, respectively. The mean postoperative manifest refractive sphere and cylinder was -0.30±0.51D and -0.81±1.51D, respectively. There was a significant reduction in refractive astigmatism after toric IOL implantation (P<0.002). The toric IOL axis rotation was <5° in all cases at the final follow-up. Conclusions: Implantation of hydrophobic toric IOL was a safe and effective surgical procedure to correct mild to moderate stable PMD. © 2015 Macmillan Publishers Limited All rights reserved