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

NCT ID: NCT06256770

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-01

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

scleral contact lenses group

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.

No interventions assigned to this group

RGP group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Wang, Prof

Role: STUDY_CHAIR

Tianjin Eye Hospital

Locations

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinyu Yang

Role: CONTACT

yxydoctor0725@163.com

022-27313336

Facility Contacts

yan wang, director

Role: primary

wangyan7143@vip.sina.com

+862227313336

Other Identifiers

zhangyi2023

Identifier Type: -

Identifier Source: org_study_id