Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults
NCT ID: NCT06528860
Last Updated: 2024-07-30
Study Results
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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NOT_YET_RECRUITING
NA
144 participants
INTERVENTIONAL
2024-08-31
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)
TREATMENT
TRIPLE
Study Groups
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Dual-focus CL
Wearing dual-focus CL for 2 years
MiSight® 1 day soft contact lenses
Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Single-vision CL
Wearing single-vision CL for 2 years
Proclear® 1 day soft contact lenses
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%.
Proclear® 1 day soft contact lenses
Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
25 Years
ALL
No
Sponsors
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Shanghai Eye Disease Prevention and Treatment Center
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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QX-2024-A-002
Identifier Type: -
Identifier Source: org_study_id
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