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

Tianjin Eye Hospital

Status: Enrolling

Conditions: Irregular Astigmatism; Corneal Astigmatism; Contact Lens Complication; Ocular Surface Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06256770

zhangyi2023

Details and patient eligibility

About

To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.

Enrollment: 176 estimated patients

Sex: All

Ages: 8 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

176 participants in 2 patient groups

scleral contact lenses group

Description:

The selected patients were equipped with scleral contact lenses to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses.

RGP group

Description:

The selected patients were equipped with RGP to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses.