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Not yet recruiting NCT06528860

Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults

No phase Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MiSight® 1 day soft contact lenses, Proclear® 1 day soft contact lenses.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial

Overview

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Detailed description

It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Interventions

  • Device MiSight® 1 day soft contact lenses
    Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
  • Device Proclear® 1 day soft contact lenses
    Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.

Primary outcome measures

  • Change in cycloplegic spherical equivalent after 2 years [Time frame: 2 years after the baseline]
Secondary outcome measures (1)
  • Change in axial length after 2 years [Time frame: 2 years after the baseline]

Eligibility criteria

Inclusion criteria

  • Age 18-25 years;
  • Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
  • The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
  • The subject eye's best corrected visual acuity <= logMAR 0.1;
  • Anisometropia does not exceed 1.50D.

Exclusion criteria

  • Current use of MC interventions or prior use of MC interventions within the past 6 months;
  • Disease or anatomical factors that affect the wearing of contact lenses;
  • History of myopia correction surgery;
  • Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
  • pregnant female;
  • Other conditions deemed unsuitable by the investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Eye Disease Prevention & Treatment Center — Shanghai

Publications

  • Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11. PMID 32915454
  • Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2. PMID 37126362

Identifiers

NCT: NCT06528860 · QX-2024-A-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗