A randomized controlled trial comparing femtosecond laser–assisted cataract surgery versus conventional phacoemulsification surgery

Roberts, Harry; Wagh, Vijay B; Sullivan, Daniel; Hidzheva, Polina; Detesan, Delia I; Heemraz, B. Sanjeev; Sparrow, J M; O’Brart, David

doi:10.1016/j.jcrs.2018.08.033

Cited by 68 publications

(80 citation statements)

References 41 publications

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“…These are similar to the 0.15 logMAR for both FLACS and PCS at 1 month postoperatively in the recent RCT from St. Thomas’ Hospital, United Kingdom, of 400 eyes of 400 patients. 16 We found no difference between arms for health-related quality of life as measured by the EQ-5D-3L questionnaire and vision bolt-on question (EQ-5DV) or patient-reported vision status using Catquest–9SF, a Rasch-validated instrument. For refractive outcomes, 71% of both FLACS and PCS cases were within ±0.5 D target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D target compared with 73% and 93% eyes being within ±0.5 D and ±1.0 D target in a recent large EUREQUO (European Registry of Quality Outcomes) analysis of 282 811 cataract surgeries.…”

Section: Discussionmentioning

confidence: 57%

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Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT)

et al. 2020

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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.

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Section: Discussionmentioning

confidence: 57%

“…Two large RCTs have recently been published: the French FEMCAT (Femtosecond Laser Assisted Cataract Surgery) trial, 15 and a UK trial of 400 eyes that found similar visual outcomes between arms and a statistically significantly lower posterior capsule tear rate in the laser arm. 16 …”

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confidence: 99%

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT)

et al. 2020

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“… 79 While it offers potential advantages in terms of automation of some of the surgical steps of cataract surgery, clinical outcomes appear to be no better than those with PCS. 80 , 81 At present there is limited evidence on the long-term effects of FLACS on the ocular surface, although there are a number of studies which indicate that akin to PCS, FLACS also leads to signs and symptoms of DED. 82 , 83 …”

Section: The Pathophysiology Of Cataract Surgery Associated Dedmentioning

confidence: 99%

Cataract surgery and dry eye disease: A review

Naderi

Gormley

O’Brart

2020

European Journal of Ophthalmology

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Aim To review published literature concerning cataract surgery and dry eye disease (DED). Methods A search was undertaken using the following: PubMed (all years), Web of Science (all years), Ovid MEDLINE(R) (1946 to 12 December 2019), Ovid MEDLINE(R) Daily Update 10 December 2019, MEDLINE and MEDLINE non-indexed items, Embase (1974–2019, week 49), Ovid MEDLINE (R) and Epub Ahead of Print, In-Process and Other Non-Indexed Citations and Daily (1946 to 12 December 2019), CENTRAL (including Cochrane Eyes and Vision Trials Register; Cochrane Library: Issue 12 of 12 December 2019), metaRegister of Controlled Trials (mRCT) ( www.controlled-trials.com ), ClinicalTrials.gov ( www.clinicaltrial.gov ) and WHO International Clinical Trials Registry Platform ( www.who.int/ictrp/search/en ). Search terms included ‘cataract surgery’, ‘phacoemulsification’ and ‘cataract extraction’, combined with ‘dry eyes’ and ‘ocular surface’. Relevant in-article references not returned in our searches were also considered. Results Publications identified included systematic reviews, meta-analysis, randomized controlled trials, cohort studies, case series and laboratory-based studies. Published data highlighting the burden of DED both prior and following cataract surgery were reviewed as well as studies highlighting the effects of cataract surgery on the ocular surface, intra-operative measures to reduce deleterious effects on the ocular surface and current evidence on the management options of post-operative DED. Conclusions DED is common and can be exacerbated by cataract surgery. Ophthalmologists need to assess for pre-existing DED and instigate treatment before surgery; be aware of reduced accuracy of measurements for surgical planning in the presence of DED; limit intra-operative surgical factors damaging to the ocular surface; and consider management to reduce DED post-operatively.

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“…By contrast, several studies reported that FLAC did not show any significant improvement in the refractive and visual outcomes [51,[82][83][84], although the reduction in EPT might validate the safety and efficacy of FLACS [84]. Roberts et al [85] recently revealed that FLACS showed a significant reduction in posterior capsule ruptures, although it did not result in any significant differences with respect to the visual outcome, refractive error, and corneal endothelial injury.…”

Section: Clinical Outcomementioning

confidence: 95%

Application of Femtosecond Laser in Anterior Segment Surgery

Han

Liu

Mohamed-Noriega

2020

Journal of Ophthalmology

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Femtosecond laser (FSL) is a near-infrared laser that can create reliable and reproducible tissue cutting with minimal damage to adjacent tissue. As the laser can also create incisions with various orientations, depths, and shapes, it is expected to be a useful tool for anterior segment surgery, such as cornea, refractive, and cataract surgery. In this review, the authors will introduce the application of FSL in various anterior segment surgeries and discuss the results of studies regarding the efficacy and safety of FSL in cornea, refractive, and cataract surgery. Experimental studies regarding the potential use of FSL will also be introduced. The studies discussed in this review suggest that FSL may be a useful tool for improving the prognosis and safety of surgeries of the anterior segment.

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A randomized controlled trial comparing femtosecond laser–assisted cataract surgery versus conventional phacoemulsification surgery

Abstract: A randomized controlled trial comparing femtosecond laser-assisted cataract surgery versus conventional phacoemulsification surgery.

Cited by 68 publications

References 41 publications

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT)

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT)

Cataract surgery and dry eye disease: A review

Application of Femtosecond Laser in Anterior Segment Surgery

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