ametropia
Conditions
Interventions
Experimental group:scleral contact lens (model: SMFGP)
Control group:Scleral contact lenses that are already on the market
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Presence of irregular or regular astigmatism, with expected post-lens fitting overrefraction range from -25.00D to +25.00D (inclusive). (2) Best-corrected visual acuity with spectacles better than uncorrected visual acuity. (3) Ability to understand the purpose of the trial, voluntary participation, and signing of an informed consent form by the subject or their legally authorized guardian, and ability to complete follow-up visits on time.
Exclusion criteria
Exclusion criteria: (1) Various eye diseases requiring further treatment, including but not limited to: acute or chronic inflammation of the eye, corneal sensory abnormalities, corneal endothelial abnormalities, glaucoma, high intraocular pressure (IOP >21mmHg), eye tumors, pterygium, etc., as judged by the investigator as unfit for lens wear. (2) History of corneal transplantation. (3) Systemic diseases causing immunodeficiency or that may affect the wearing of rigid contact lenses. (4) History of allergy to contact lenses or contact lens care solutions. (5) Active allergic reactions on the ocular surface or adnexa, or worsening due to lens wear or use of lens care solutions. (6) Living or working environment unsuitable for contact lens wear, such as airborne dust, drugs, aerosols, dust, etc., or long-term exposure to environments with high dust and pollution, and contact with chemical gases. (7) Use of drugs during the study period that may affect the wearing of rigid contact lenses, cause dry eyes, affect vision and corneal curvature, or alter normal eye physiology [such as immunosuppressants, corticosteroids, intraocular pressure-lowering drugs, mydriatics (excluding ophthalmic examination), miotics, etc.]. (8) Discontinuation of soft contact lenses for less than 1 week, rigid gas-permeable corneal contact lenses (RGP) for less than 2 weeks, or corneal reshaping lenses for less than 30 days. (9) Difficulty fitting trial lenses. (10) Participation in other drug or medical device clinical trials within 30 days before screening. (11) High sensitivity and unrealistic expectations, or presence of severe anxiety, depression, or other psychological or mental illnesses. (12) Pregnant or lactating women, or those planning to become pregnant in the near future. (13) Other conditions judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy with scleral contact lenses at 1 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity with scleral lenses;Refraction with scleral lenses;Subjective acceptability; | — |
Countries
China
Contacts
Public ContactMa Ke
West China Hospital, Sichuan University
Outcome results
None listed