Ametropia
Conditions
Interventions
Experimental group:Wear a rigid contact lens (Model, specification: RGP100) produced by Suzhou Gaovision HD Medical Technology Co., LTD.
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
7 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Age 7 (inclusive) to 12 (exclusive) years old; 2. Objective optometry after ciliary paralysis SER: -0.50 to -6.00 diopter (D); 3. No myopia prevention and control measures (such as orthokeratology glasses, defocusing lenses, etc.) have been used in the past 1 month; 4. Have not used 0.01% atropine in the past 1 month or have not used other concentrations of atropine; 5. Be willing to undergo scheduled tests and follow-up visits.
Exclusion criteria
Exclusion criteria: 1.History of corneal surgery or eye surgery within the past few years; 2. Eyelid abnormalities or infection; 3. Have other active eye diseases; 4. Abnormal intraocular pressure (intraocular pressure 21mmHg or intraocular pressure difference >= 5mmHg); 5. Have a systemic condition that may affect the eyes, such as sinusitis, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, or other conditions that researchers consider impossible to wear rigid contact lenses; 6. Patients who need to use therapeutic eye drops, including antibiotics, mydriatic agents, corticosteroid hormones and compound eye drops containing corticosteroid hormones; 7. Cannot be worn for at least 8 hours a day and at least 6 days a week as required; 8. Can not accept the comfort of wearing RGP; 9. Suffering from other eye diseases other than fundus changes related to adolescent early onset myopia (such as pathological myopia); 10. One eye meets the inclusion criteria; 11. The researchers determined that the candidates could not be accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the objective optometric equivalent bulb (SER) relative to baseline length after 6 months ±14 days of cycloplegia; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of axial length of the eye from baseline at 3 months +14 months after wearing glasses;Wear satisfaction assessment; | — |
Countries
China
Contacts
Public ContactChen Zhi
Eye & ENT Hospital of Fudan University
Outcome results
None listed