Evidence map›Paper›PMID 33648464›Full record

Trial reportBMC ophthalmology2021

Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight® Assessment Study Spain (MASS).

Daniela Lopes-Ferreira, Alicia Ruiz-Pomeda, Belén Peréz-Sanchéz, António Queirós, César Villa-Collar

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01917110 (Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 29% 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.

NCT01917110 nacompletednot on this map

Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.

TypeinterventionalSponsorCooperVision, Inc.Ran2013 to 2016Enrolled79ConditionsMyopiaArmsomafilcon A, Spectacle
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. [Visual Performance of School-age Children Wearing Dual-Focus Soft Contact Lenses: A Randomized Controlled Trial].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2024
    Trial
  4. Corneal higher-order aberrations in early-onset cataract patients without identifiable risk factors: a retrospective case-control study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  5. Review
  6. Article
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

5 authors at 4 institutions in 2 countries.

Daniela Lopes-FerreiraCEORLab, Centre of Physics, Clinical and Experimental Optometry Research Lab, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal. dlopes-ferreira@fisica.uminho.pt.
Alicia Ruiz-PomedaServicio de Oftalmología. Hospital Universitario de Mostoles, Mostoles, Madrid, Spain.
Belén Peréz-SanchézDepartment of Statistics, Mathematics and Informatics, Area of Languages and Computer Systems, Miguel Hernández University of Elche, Elche, Alicante, Spain.
António QueirósCEORLab, Centre of Physics, Clinical and Experimental Optometry Research Lab, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.
César Villa-CollarDepartment of Pharmacy, Biotechnology, Optics and Optometry, European University of Madrid, C/Tajo s/n, 28670, Villaviciosa de Odón, Madrid, Spain.
University of Minho · PTHospital Universitario de Móstoles · ESUniversidad Europea de Madrid · ESUniversitat de Miguel Hernández d'Elx · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo compare ocular and corneal inherent aberrations in the naked eyes of randomly selected children fitted with MiSight contact lenses (CL) for myopia control, versus children corrected with single-vision spectacles (control), over a 24-months period.

methodsChildren aged 8 to 12 years, with myopia (-0.75 to -4.00 D sphere) and astigmatism (< -1.00 D cylinder) were randomly assigned to the lens study group (MiSight) or the control group (single-vision spectacles). The root mean square aberration (RMS) was determined as corneal (RMS_C), corneal high order RMS (HO_RMS_C), corneal low order RMS (LO_RMS_C), ocular (total) RMS (RMS_T), ocular high order RMS (HO_RMS_T), ocular low order RMS (LO_RMS_T), corneal spherical aberration (SA_C) and ocular SA (SA_T) were calculated by aberrometry measures at the baseline, on 12-months and 24-months visits. A 5 mm diameter was defined for the analysis in all visits for all subjects. Only the dominant eye was analyzed.

resultsSeventy-four subjects completed the clinical trial: 41 subjects from the MiSight group (age: 11.01 ± 1.23 years) and 33 from the single-vision group (age: 10.12 ± 1.38 years). RMS_T significantly changed (0.57 ± 0.20 µm, p = 0.029) after 24-months in the control group. In the MiSight group no significant changes were registered (p > 0.05). The SA_C and SA_T did not reveal significant changes between visits or between groups (p > 0.05).

conclusionsAlong 2 years, MiSight CL did not induce significant changes in RMS of anterior cornea or total ocular RMS. Contrary, in control group the RMS_T significantly changed as response of greater eye growth and myopia progression. The results obtained in present study allow to predict corneal or total aberration changes, in children, in response of wearing of MiSight lens along the time.

trial registrationClinicalTrials.gov Identifier: NCT01917110.

Indexed as

Contact Lenses, HydrophilicMyopiaChildCorneaCorneal TopographyHumansRefraction, OcularSpainAxial growthChildrenContact lensesMiSightMyopia

Identifiers

PMID33648464
PMCPMC7919067
OpenAlexW3134038552

What OpenQuestion holds

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LicenceCC BY
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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.