Evidence map›Paper›PMID 32386810›Full record

Trial reportOphthalmology2020

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

Alexander C Day, Jennifer M Burr, Kate Bennett, Catey Bunce, Caroline J Doré, Gary S Rubin, Mayank A Nanavaty, Kamaljit S Balaggan, Mark R Wilkins, FACT group

Abstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  12. Update on Femtosecond Laser-Assisted Cataract Surgery: A Review.Clinical ophthalmology (Auckland, N.Z.) · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Alexander C DayThe NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: alex.day@ucl.ac.uk.
Jennifer M BurrSchool of Medicine, University of St. Andrews, Fife, Scotland.
Kate BennettUCL Comprehensive Clinical Trials Unit, London, United Kingdom.
Catey BunceDepartment of Primary Care & Public Health Sciences, King's College London, London, United Kingdom.
Caroline J DoréUCL Comprehensive Clinical Trials Unit, London, United Kingdom.
Gary S RubinUCL Institute of Ophthalmology, London, United Kingdom.
Mayank A NanavatySussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, United Kingdom.
Kamaljit S BalagganWolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands, United Kingdom.
Mark R WilkinsThe NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom.
FACT group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Visual AcuityAgedCost-Benefit AnalysisFemaleFollow-Up StudiesHumansLaser TherapyMalePhacoemulsificationRetrospective StudiesTreatment Outcome

Identifiers

PMID32386810
PMCPMC7397499

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.