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

Shanghai Eye Disease Prevention and Treatment Center

Status: Not yet enrolling

Conditions: Myopia

Treatments: Device: MiSight® 1 day soft contact lenses; Device: Proclear® 1 day soft contact lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT06528860

QX-2024-A-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

Dual-focus CL

Experimental group

Description:

Wearing dual-focus CL for 2 years

Treatment:

Device: MiSight® 1 day soft contact lenses

Single-vision CL

Placebo Comparator group

Description:

Wearing single-vision CL for 2 years

Treatment:

Device: Proclear® 1 day soft contact lenses