myopia
Conditions
Interventions
Blue Light Blocking (B12):Blue Light Blocking (B12)
Star Shine Monthly (PMB):Star Shine Monthly (PMB)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 45 years (inclusive), no restrictions on gender. 2.Best-corrected visual acuity (BCVA) in both eyes, as determined by subjective refraction, is greater than or equal to 5.0. 3.Subjective refraction shows myopia in both eyes ranging from -1.00D to -8.00D, astigmatism =1.50D, and a sphere-to-cylinder ratio =3:1. 4.Fully informed about the trial and voluntarily agrees to participate, with the informed consent form signed by the participant or their legal guardian.
Exclusion criteria
Exclusion criteria: 1.Patients with eye diseases deemed unsuitable for contact lens wear by the investigator, such as acute or chronic ocular inflammation, glaucoma, corneal hypoesthesia, corneal epithelial defects, corneal endothelial cell loss, dry eye syndrome, etc. 2.Patients with systemic diseases that may affect the eyes, such as diabetes, hyperthyroidism, rheumatoid arthritis, or a history of sinusitis, deemed unsuitable for contact lens wear by the investigator. 3.Patients requiring the use of any local or systemic medication during the study period that may interfere with contact lens wear or necessitate removal during the day, or those currently using systemic or ocular medications that prohibit or impair contact lens performance (e.g., glaucoma eye drops, steroid anti-inflammatory eye drops). Common vision-affecting medications include tricyclic antidepressants, phenothiazines, and immunomodulators. 4.Abnormal intraocular pressure (IOP 21 mmHg or interocular IOP difference > 5 mmHg). 5.History of allergy to contact lenses or contact lens care products. 6.History of refractive surgery or irregular corneas. 7.Patients unable to follow instructions for wearing and caring for the investigational device or whose living/working environments are unsuitable for soft lens wear, such as exposure to airborne dust, chemicals, aerosols (e.g., hairspray, volatile chemicals), or heavy dust. 8.Patients judged by the investigator to lack the necessary hygiene standards required for soft contact lens wear. 9.Pregnant or breastfeeding women, or those planning to conceive in the near future. 10.Patients with severe mental or psychological disorders that prevent them from completing the trial. 11.Patients who have worn orthokeratology lenses within the past month or have not discontinued wearing other rigid or soft contact lenses within the past week. 12.Patients who have participated in other clinical trials within the past month that may affect this study. 13.Any other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lens-Wearing Effectiveness Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Left and Right Eye Contact Lens-Wearing Effectiveness Rate; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital, Wenzhou Medical University
Outcome results
None listed