Evidence map›Paper›PMID 41346031›Full record

ArticleBMJ open ophthalmology2025

Establishing non-inferiority margins in myopia management contact lens trials with an active control.

Ravi Chandra Bakaraju, Daniel Tilia

Abstract read
In one paragraph

Article in BMJ open ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

2 authors.

Ravi Chandra Bakarajunthalmic Pty Ltd, Botany, New South Wales, Australia r.bakaraju@nthalmic.com.ORCID 0009-0000-0280-0966
Daniel Tilianthalmic Pty Ltd, Botany, New South Wales, Australia.ORCID 0000-0002-3917-9699

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The myopia control field stands at an ethical crossroads. Withholding proven soft contact lens interventions in control arms of myopia management trials is increasingly viewed as ethically questionable and operationally challenging, particularly given that MiSight 1-day contact lens has demonstrated efficacy in at least four randomised controlled trials. The recent methodological evolution towards non-inferiority trials against an established control rather than a placebo (single vision) is a welcome change. However, this shift raises a critical challenge: setting non-inferiority margins that are both clinically meaningful and statistically robust.

Indexed as

Contact Lenses, HydrophilicEquivalence Trials as TopicMyopiaRandomized Controlled Trials as TopicRefraction, OcularHumansResearch DesignContact lensOptics and Refraction

Identifiers

PMID41346031
PMCPMC12682156

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.