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

NCT ID: NCT06528860

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%).

Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This study will utilize a Central Randomization System (CRS) for the random grouping and glasses allocation of study subjects during the clinical trial. Investigators and participants will be blinded to the intervention received until unblinding.

Study Groups

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Dual-focus CL

Wearing dual-focus CL for 2 years

Group Type EXPERIMENTAL

MiSight® 1 day soft contact lenses

Intervention Type DEVICE

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

Single-vision CL

Wearing single-vision CL for 2 years

Group Type PLACEBO_COMPARATOR

Proclear® 1 day soft contact lenses

Intervention Type DEVICE

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

Interventions

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MiSight® 1 day soft contact lenses

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

Intervention Type DEVICE

Proclear® 1 day soft contact lenses

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

Intervention Type DEVICE

Other Intervention Names

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CooperVision CooperVision

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiangui He

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Disease Prevention & Treatment Center

Locations

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Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiangui He

Role: CONTACT

(86)15000755422

Hotin Wu

Role: CONTACT

(86)19821287621

Facility Contacts

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Xiangui He

Role: primary

(86)15000755422

Hotin Wu

Role: backup

(86)19821287621

References

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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.

Reference Type BACKGROUND
PMID: 32915454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37126362 (View on PubMed)

Other Identifiers

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QX-2024-A-002

Identifier Type: -

Identifier Source: org_study_id

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