Evidence map›Paper›PMID 26614627›Full record

Trial reportBMJ open2015

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.

Alexander C Day, Jennifer M Burr, Catey Bunce, Caroline J Doré, Yvonne Sylvestre, Richard P L Wormald, Jeff Round, Victoria McCudden, Gary Rubin, Mark R Wilkins and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Eye surgery in the elderly.Clinical interventions in aging · 2016
    Review
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

11 authors at 3 institutions in 1 country.

Alexander C DayUCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.ORCID http://orcid.org/0000-0002-2099-8870
Jennifer M BurrUniversity of St Andrews, Scotland, Fife, UK.
Catey BunceUCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.ORCID http://orcid.org/0000-0002-0935-3713
Caroline J DoréUCL Comprehensive Clinical Trials Unit, London, UK.
Yvonne SylvestreUCL Comprehensive Clinical Trials Unit, London, UK.
Richard P L WormaldUCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Jeff RoundUCL Comprehensive Clinical Trials Unit, London, UK.
Victoria McCuddenUCL Comprehensive Clinical Trials Unit, London, UK.
Gary RubinUCL Institute of Ophthalmology, University College London, London, UK The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
Mark R WilkinsThe NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
FACT Group
Moorfields Eye Hospital NHS Foundation Trust · GBMRC Clinical Trials Unit at UCL · GBUniversity of St Andrews · GB

Funding

Department of Health HTA/13/04/46Department of Health NIHR-RP-011-045
6 · The paper itself

Abstract

introductionCataract 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN: 77602616.

Indexed as

Research DesignAdolescentAdultAgedAged, 80 and overCataractCataract ExtractionFemaleHumansLaser TherapyMaleMiddle AgedPhacoemulsificationProspective StudiesReproducibility of ResultsSingle-Blind MethodLaser assisted cataract surgeryPhacoemulsification cataract surgeryRandomised controlled trial

Identifiers

PMID26614627
PMCPMC4663449
OpenAlexW2221680331

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.