Evidence map›Paper›PMID 41436254›Full record

ArticleBMJ open2025

Keratorefractive lenticule extraction (KLEx) versus femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for the treatment of myopia and compound myopic astigmatism: study protocol of a randomised clinical trial in Mexico.

Mauricio Muleiro-Alvarez, Guillermo Raul Vera-Duarte, Eber A Medina-Estrada, Gustavo Ortiz-Morales, Arturo Ramirez-Miranda, Alejandro Navas, Enrique L Graue-Wiechers, Enrique O Graue-Hernandez, Nicolás Kahuam-López

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06477081 (Keratorefractive Lenticule Extraction), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT06477081 naactive not recruitingnot on this map

Keratorefractive Lenticule Extraction (KLEx) Versus Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK) for the Treatment of Myopia and Compound Myopic Astigmatism

TypeinterventionalSponsorInstituto de Oftalmología Fundación Conde de ValencianaRan2024 to 2027Enrolled80ConditionsMyopia, Astigmatism, Myopic AstigmatismArmsFS-LASIK procedure, KLEx
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Mauricio Muleiro-AlvarezCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Guillermo Raul Vera-DuarteCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Eber A Medina-EstradaCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Gustavo Ortiz-MoralesCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Arturo Ramirez-MirandaCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Alejandro NavasCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Enrique L Graue-WiechersCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Enrique O Graue-HernandezCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Nicolás Kahuam-LópezCornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico nkahuam@gmail.com.ORCID http://orcid.org/0000-0003-3887-0629

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionKerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism. METHODS AND ANALYSIS: This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere -0.50 to -12.00 D and cylinder -0.50 to -6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique. ETHICS AND DISSEMINATION: Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT06477081).

Indexed as

AstigmatismKeratomileusis, Laser In SituMyopiaAdultDouble-Blind MethodFemaleHumansMaleMexicoRandomized Controlled Trials as TopicRefraction, OcularTreatment OutcomeVisual AcuityYoung AdultCataract and refractive surgeryCorneal and external diseasesMyopia

Identifiers

PMID41436254
PMCPMC12730775

What OpenQuestion holds

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Registered trials

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.