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NCT Number: NCT06528860

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MiSight® 1 day soft contact lenses

Device

Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.

Other names: CooperVision

Proclear® 1 day soft contact lenses

Device

Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.

Other names: CooperVision

Primary outcomes

  1. Change in cycloplegic spherical equivalent after 2 years

    Time frame: 2 years after the baseline

    The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.

Secondary outcomes

  1. Change in axial length after 2 years

    Time frame: 2 years after the baseline

    The difference in the change of axial length between the intervention group and the control group.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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