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

Not Applicable

Not yet recruiting

• Conditions: Myopia
• Interventions: Device: MiSight® 1 day soft contact lenses; Device: Proclear® 1 day soft contact lenses

• Registration Number: NCT06528860
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-08-31
• Primary Completion: 2027-06-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual-focus CL	MiSight® 1 day soft contact lenses	Wearing dual-focus CL for 2 years
Single-vision CL	Proclear® 1 day soft contact lenses	Wearing single-vision CL for 2 years

Primary Outcome Measures

Name	Time	Method
Change in cycloplegic spherical equivalent after 2 years	2 years after the baseline	The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.

Secondary Outcome Measures

Name	Time	Method
Change in axial length after 2 years	2 years after the baseline	The difference in the change of axial length between the intervention group and the control group.

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Shanghai, China