Myopia
Conditions
Keywords
Myopia, Dual-focus contact lenses, Young adults, Adult myopia progression
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.
Interventions
DEVICEMiSight® 1 day soft contact lenses
Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
DEVICEProclear® 1 day soft contact lenses
Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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%)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXiangui He
Backup ContactHotin Wu
Outcome results
None listed