Evidence map›Paper›PMID 33511963›Full record

Trial reportHealth technology assessment (Winchester, England)2021

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

Alexander C Day, Jennifer M Burr, Kate Bennett, Rachael Hunter, Catey Bunce, Caroline J Doré, Mayank A Nanavaty, Kamaljit S Balaggan, Mark R Wilkins

Open access · diamondAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
4.3field-weighted citation impact, top 5% of its field
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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Update on Femtosecond Laser-Assisted Cataract Surgery: A Review.Clinical ophthalmology (Auckland, N.Z.) · 2024
    Review
  7. Article
  8. Review
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  11. Article
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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

9 authors at 6 institutions in 1 country.

Alexander C DayThe National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-2099-8870
Jennifer M BurrSchool of Medicine, University of St Andrews, St Andrews, UK.ORCID 0000-0002-9478-738X
Kate BennettUCL Comprehensive Clinical Trials Unit (CCTU), London, UK.ORCID 0000-0002-2358-4497
Rachael HunterUCL Comprehensive Clinical Trials Unit (CCTU), London, UK.ORCID 0000-0002-7447-8934
Catey BunceDepartment of Primary Care and Public Health Sciences, King's College London, London, UK.ORCID 0000-0002-0935-3713
Caroline J DoréUCL Comprehensive Clinical Trials Unit (CCTU), London, UK.ORCID 0000-0001-9796-4970
Mayank A NanavatySussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.ORCID 0000-0003-0667-3700
Kamaljit S BalagganWolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, UK.ORCID 0000-0003-2561-6664
Mark R WilkinsThe National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-8742-9162
MRC Clinical Trials Unit at UCL · GBMoorfields Eye Hospital NHS Foundation Trust · GBKing's College London · GBNew Cross Hospital · GBSussex Eye Hospital · GBUniversity of St Andrews · GB

Funding

Department of Health 13/04/46
6 · The paper itself

Abstract

backgroundCataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps.

objectivesTo compare FLACS with phacoemulsification cataract surgery (PCS).

designMulticentre, outcome-masked, randomised controlled non-inferiority trial.

settingThree collaborating NHS hospitals.

participantsA total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017.

interventionFLACS (

main outcome measuresThe 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.

resultsA 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; LIMITATIONS: Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked.

conclusionsThe 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 registrationCurrent Controlled Trials ISRCTN77602616.

fundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in

Indexed as

CataractCataract ExtractionLaser TherapyPhacoemulsificationHumansLasersCORRECTED DISTANCE VISUAL ACUITYFEMTOSECOND LASER-ASSISTED CATARACT SURGERYINCREMENTAL COST-EFFECTIVENESS RATIOLAY ADVISORY GROUPLOG OF THE MINIMUM ANGLE OF RESOLUTIONPHACOEMULSIFICATION CATARACT SURGERYQUALITY-ADJUSTED LIFE-YEARUNAIDED DISTANCE VISUAL ACUITY

Identifiers

PMID33511963
PMCPMC7883211
OpenAlexW3124973405

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.