Study on the effects of myopia progression and visual function by wearing multifocal soft contact lens

• Register: ChiCTR
• Last refreshed on: 24 July 2017
• Main ID: ChiCTR-OOC-17012103
• Date of registration: 2017-07-23
• Prospective Registration: Yes
• Primary sponsor: The Eye Hospital of Wenzhou Medical University
• Public title: Study on the effects of myopia progression and visual function by wearing multifocal soft contact lens
• Scientific title: Study on the effects of myopia progression and visual function by wearing multifocal soft contact lens
• Date of first enrolment: 2017-08-01
• Target sample size: Multifocal soft contact lens group:46;Spectacle group:46;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=20622
• Study type: Observational study
• Study design: Cohort study
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Fan Jiang
• Affiliation: The Eye Hospital of Wenzhou Medical University

• Name: Jun Jiang

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 8-14 year-old myopia, male or female;
2. Subject Refraction: -1.00D=Equal Sphere=-8.00D,Corneal Astigmatism=1.50D;
3. 0.50D or more Myopia Progression in the last year;
4. Being able to complete at least 12 months of follow-up;
5. Being able to understand the purpose of the test, participating voluntarily and signing the informed consent form by the subject himself and his legal guardian.
Exclusion criteria: 1. Patients with systemic diseases that may affect the eyes, such as diabetes, thyroid abnormalities, arthritis, allergic diseases, etc., the patients that can not wear contact lens judged by ophthalmologist;
2. With all kinds of eye disease, such as acute or chronic inflammation of the eye, glaucoma, secondary or more abnormal corneal sensation, deficiency of corneal epithelium, reduced corneal endothelial cells, dry eyes, etc., the patients that can not wear contact lens judged by ophthalmologist;
3. Abnormal cornea;Patients with corneal surgery, history of corneal trauma, active keratitis (such as corneal infection, etc.), corneal limbus protrusion, severe blepharoptosis, or nearby uplift areas;
4. The best corrected vision for the spectacle was less than 0.8;
5. Living or working conditions are not suitable for wearing contact lenses, such as dispersing dust, drugs, aerosol (such as hairspray, volatile chemicals), dust, etc.
6. Can not use contact lens and do eye examinations as required, and refractive instability;
7. Personal hygiene conditions do not meet the requirement to wear contact lenses;
8. Strabismus patients, amblyopia and abnormal ocular position;
9. Subjects who have worn Ortho-K and have used atropine or pirenzepine in the last 30 days;
10. Subject of allergic history of contact lens or contact lens care products;
11. The test results indicate that subjects with contraindications or not suitable to wear corneal contact lenses;
12. Having a history of ocular trauma or intraocular surgery;
13. Participated in clinical trials of other drugs or medical devices within 30 days;
14. Unsupervised or unable to follow the advice of the doctors;
15. Other situations that the patients were not suitable judged by the researchers.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

ametropia

Intervention(s)

Multifocal soft contact lens group:Wearing multifocal soft contact lens group;Spectacle group:Wearing spectacle;

Primary Outcome(s)

Axial lengths;Peripheral refraction;Accommodative function;Abberation;Accommodative microfluctuation;

Source(s) of Monetary Support

The head of research project fund