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

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorShanghai Eye Disease Prevention and Treatment Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • MiSight® 1 day soft contact lenses

    Device

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

  • Proclear® 1 day soft contact lenses

    Device

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

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Dual-focus CLExperimental treatment 1 intervention
Group B: Single-vision CLPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in cycloplegic spherical equivalent after 2 years

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

Time frame
2 years after the baseline

Secondary outcomes

1

Change in axial length after 2 years

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

Time frame
2 years after the baseline

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: