Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia

Inclusion Criteria:

1.8 ≤ age ≤ 55 years old;2.The diopter of one or both eyes is -25.00~+25.00 D (including -25.00D and +25.00D), and corneal astigmatism caused by any reason (including keratoconus,irregular cornea) ≥0.75D.

Exclusion Criteria:

1.Patients who are judged by the investigator to be unsuitable for corneal endothelialcells;2.Dry eye ;3.Abnormal IOP ;4.Overt strabismus;5.Bacterial, fungal, viral and otheractive corneal infections;6. Being used may cause dry eyes or affect the eyeball or affectvision or affect the angle drugs such as membrane curvature;7.Corneal sensory, activecorneal lesions;8.Conventional slit lamp microscopy and ophthalmoscopy, corneal diseases,iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease oractive and progressive disease;9.Other eye diseases: such as dacryocystitis, eyeliddiseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathwaydiseases, glaucoma;10.Patients with systemic diseases that cause immunocompromise;Historyof allergy to contact lenses or contact lens care solution;11.History of allergy to contactlenses or contact lens care solution;12.Pregnant, lactating or planning to become pregnantin the near future;13.Subjects who are considered by the investigator to be unable to wearrigid contact lenses after comprehensively considering the corneal parameters,morphological characteristics and refractive examination results of the examinationresults;14.Those who have worn hard contact lenses within 30 days or soft hydrophiliccontact lenses within 10 days;15.Those who participated in other drug clinical trials 3months before screening and participated in other medical device clinical trials within 30days;16.one-eyed patients;17.Those who have a strong sense of foreign body and cannottolerate it and have poor compliance, and cannot be timely and regular to the medicalinstitution for medical treatment as required;18.Other conditions judged by theinvestigator that the patient is not suitable for enrollment.